Panels › Hematology › Product code GKH · Class 1
Apparatus, Automated Blood Cell Diluting
Regulation 864.5240
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GKH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2010 | K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 Veridex, LLC | GKH |
| Mar 12, 2004 | K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM Immunicon Corp. | GKH |
| Sep 30, 2002 | K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 Immunicon Corp. | GKH |
| Jun 11, 2002 | K021150 | COULTER CELLPREP Beckman Coulter, Inc. | GKH |
| Mar 11, 1994 | K935953 | COULTER MULTI Q PREP Coulter Corp. | GKH |
| Oct 14, 1992 | K923530 | COULTER MULTI-Q-PREP Coulter Electronics, Inc. | GKH |
| Dec 31, 1990 | K904795 | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKH |
| Jul 18, 1988 | K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM Toa Medical Electronics USA, Inc. | GKH |
| Jul 5, 1985 | K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR Abbott Diagnostics | GKH |
| Oct 1, 1984 | K842747 | HYCEL DILUTOR, VARIOUS MODELS/MULTI R&D Systems, Inc. | GKH |
| Sep 6, 1984 | K842446 | DILU-MATIC 140 Abbott Diagnostics | GKH |
| Dec 28, 1982 | K823522 | DILULAB 230 Innovative Medical Systems, Inc. | GKH |
| Sep 19, 1979 | K791644 | ROYCO MODEL 371 SUPER DILUTOR Royco Instruments | GKH |
| Feb 7, 1977 | K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE Ortho Diagnostics, Inc. | GKH |
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