Panels › Hematology › Product code GKF · Class 2
Instrument, Hematocrit, Automated
Regulation 864.5600
0510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GKF
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corp. | 3 | 0 |
| Fisher Scientific Co., LLC | 2 | 0 |
| Arden Medical Systems, Inc. | 1 | 0 |
| Cobe Laboratories, Inc. | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| In-Line Diagnostics Corp. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Plaza Medical, Inc. | 1 | 0 |
| Radiometer America Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2006 | Radiometer America Inc Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC Terminated |
GKF | None listed |
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