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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2016 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Instrumentation Laboratory CO | GKF |
| May 27, 1999 | K983551 | CRIT-SCAN II MONITOR In-Line Diagnostics Corp. | GKF |
| May 12, 1998 | K981427 | STAT PROFILE M ANALYZER Nova Biomedical Corp. | GKF |
| May 12, 1998 | K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS Nova Biomedical Corp. | GKF |
| May 12, 1998 | K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS Nova Biomedical Corp. | GKF |
| Nov 3, 1995 | K953519 | MICROSPIN 24 Vulcon Technologies | GKF |
| Mar 11, 1992 | K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE Fisher Scientific Co., LLC | GKF |
| Jan 8, 1992 | K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE Fisher Scientific Co., LLC | GKF |
| Dec 27, 1990 | K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR Cobe Laboratories, Inc. | GKF |
| Mar 17, 1988 | K880373 | IONOMETER E-HK AND ACCESSORIES Smash Ent., Inc. | GKF |
| Apr 14, 1987 | K870860 | CHEMPRO 1000(TM) Arden Medical Systems, Inc. | GKF |
| Jan 5, 1987 | K864646 | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE E.I. Dupont DE Nemours & Co., Inc. | GKF |
| Oct 29, 1986 | K864039 | MICROHEMATOCRIT CENTRIFUGE Plaza Medical, Inc. | GKF |
| Feb 4, 1981 | K802199 | STAT-CRIT HEMATOCRIT MEASURING INSTRU United States Surgical, A Division of Tyco Healthc | GKF |
| Aug 14, 1978 | K781059 | CUTTER/COMPUR MINI CENTRIFUGE Cutter Laboratories, Inc. | GKF |
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