Instrumentation Laboratory CO
FDA 510(k) & PMA Approved Devices — 25 products
Total Devices25
Categories15
Latest FDA decision2023-09-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K160885 | HemosIL D-Dimer HS | DAP | 2016-10-27 | View |
| 510(k) | K161818 | GEM Premier 3000 | CGA | 2016-09-14 | View |
| 510(k) | K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | LCO | 2016-07-08 | View |
| 510(k) | K160445 | HemosIL Silica Clotting Time | GFO | 2016-03-16 | View |
| 510(k) | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | GKP | 2016-03-03 | View |
No matching devices.
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