Instrumentation Laboratory CO
FDA 510(k) & PMA Approved Produkte — 25 products
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Produkte insgesamt25
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Neueste FDA-Entscheidung
| Typ | Nummer | Produktname | Code | Datum | Aktionen |
|---|---|---|---|---|---|
| 510(k) | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glykoprotein-I IgM | JPA | 2023-09-29 | Anzeigen |
| 510(k) | K223187 | HemosIL Liquid Anti-Xa | QLU | 2023-06-23 | Anzeigen |
| 510(k) | K223090 | GEM Premier ChemSTAT | CGA | 2023-01-27 | Anzeigen |
| 510(k) | K223402 | HemosIL von Willebrand Factor Antigen | GGP | 2022-12-09 | Anzeigen |
| 510(k) | K213464 | HemosIL Liquid Anti-Xa | KFF | 2022-10-04 | Anzeigen |
| 510(k) | K213426 | HemosIL ReadiPlasTin | GJS | 2022-08-16 | Anzeigen |
| 510(k) | K203790 | GEM Premier 5000 | CHL | 2021-08-20 | Anzeigen |
| 510(k) | K200033 | HemosIL von Willebrand Factor Antigen | GGP | 2020-08-19 | Anzeigen |
| 510(k) | K183549 | GEM Premier ChemSTAT | JGS | 2019-02-16 | Anzeigen |
| 510(k) | K183546 | GEM Premier ChemSTAT | CGA | 2019-02-16 | Anzeigen |
| 510(k) | K183555 | GEM Premier ChemSTAT | JFY | 2019-02-16 | Anzeigen |
| 510(k) | K180486 | HemosIL Factor XII Deficient Plasma | GJT | 2018-03-22 | Anzeigen |
| 510(k) | K173403 | GEM Premier 5000 | CHL | 2017-12-29 | Anzeigen |
| 510(k) | K172903 | HemosIL D-Dimer HS 500 | DAP | 2017-11-22 | Anzeigen |
| 510(k) | K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | LCO | 2017-09-08 | Anzeigen |
| 510(k) | K170314 | ACL AcuStar | JPA | 2017-03-03 | Anzeigen |
| 510(k) | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | GKF | 2016-12-14 | Anzeigen |
| 510(k) | K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | CHL | 2016-12-14 | Anzeigen |
| 510(k) | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator | JGS | 2016-12-14 | Anzeigen |
| 510(k) | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | CGA | 2016-12-14 | Anzeigen |
Keine passenden Geräte.