Clinical Chemistry FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in Clinical Chemistry from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
13 clearances in the last 90 days. The same 90 days a year earlier: 7.
For contract manufacturers and test labs
Clinical Chemistry accounts for 13 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). Contract manufacturers and test labs that work on Clinical Chemistry devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 |
NBC | Test, Natriuretic Peptide | 2 |
QFG | Alternate Controller Enabled Insulin Infusion Pump | 2 |
QJI | Interoperable Automated Glycemic Controller | 2 |
JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 21, 2026 | Beta Bionics, Inc. | Mint ACE Pump | K263422 |
| Oct 21, 2026 | Sol-Millennium Medical, Inc. | Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set | K260857 |
| Oct 20, 2026 | Beckman Coulter, Inc. | Access BNP II | K262597 |
| Oct 16, 2026 | Becton, Dickinson and Company | BD Vacutainer Serum Blood Collection Tubes; BD Vacutainer Rapid Serum Tubes (RST) | K252344 |
| Oct 15, 2026 | Deka Research and Development Corp. | twiist Loop Algorithm | K262576 |
| Sep 22, 2026 | Alfa Scientific Designs, Inc. | Instant-View hCG Combo II Cassette Test | K262299 |
| Sep 21, 2026 | Beckman Coulter, Inc. | Access NT-proBNP | K262109 |
| Sep 18, 2026 | Biolinq Incorporated | Biolinq Shine Autonomous Time-in-Range Microsensor | K262599 |
| Sep 11, 2026 | Beta Bionics, Inc. | iLet Dosing Decision Software | K262763 |
| Sep 11, 2026 | Beta Bionics, Inc. | Mint ACE Pump | K260001 |
| Sep 1, 2026 | Sequitur Health Corp. | AMI Plasma Cartridge, AMI | K260613 |
| Aug 27, 2026 | Ascensia Diabetes Care | CONTOUR PLUS BLUE Blood Glucose Monitoring System; CONTOUR NEXT GEN Blood Glucose Monitoring System; CONTOUR NEXT ONE Blood Glucose Monitoring System | K260545 |
| Aug 11, 2026 | Dexcom, Inc. | Stelo Glucose Biosensor System | K262472 |
- Oct 21, 2026Beta Bionics, Inc.
Mint ACE Pump
- Oct 21, 2026Sol-Millennium Medical, Inc.
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- Oct 20, 2026Beckman Coulter, Inc.
Access BNP II
- Oct 16, 2026Becton, Dickinson and Company
BD Vacutainer Serum Blood Collection Tubes; BD Vacutainer Rapid Serum Tubes (RST)
- Oct 15, 2026Deka Research and Development Corp.
twiist Loop Algorithm
- Sep 22, 2026Alfa Scientific Designs, Inc.
Instant-View hCG Combo II Cassette Test
- Sep 21, 2026Beckman Coulter, Inc.
Access NT-proBNP
- Sep 18, 2026Biolinq Incorporated
Biolinq Shine Autonomous Time-in-Range Microsensor
- Sep 11, 2026Beta Bionics, Inc.
iLet Dosing Decision Software
- Sep 11, 2026Beta Bionics, Inc.
Mint ACE Pump
- Sep 1, 2026Sequitur Health Corp.
AMI Plasma Cartridge, AMI
- Aug 27, 2026Ascensia Diabetes Care
CONTOUR PLUS BLUE Blood Glucose Monitoring System; CONTOUR NEXT GEN Blood Glucose Monitoring System; CONTOUR NEXT ONE Blood Glucose Monitoring System
- Aug 11, 2026Dexcom, Inc.
Stelo Glucose Biosensor System
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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