FDA Product Code
FDA Product Code GKH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5240
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Veridex, LLC | 2010-08-26 | Traditional | PDF ↗ |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Immunicon Corp. | 2004-03-12 | Traditional | PDF ↗ |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Immunicon Corp. | 2002-09-30 | Traditional | PDF ↗ |
| K021150 | COULTER CELLPREP | Beckman Coulter, Inc. | 2002-06-11 | Traditional | PDF ↗ |
| K935953 | COULTER MULTI Q PREP | Coulter Corp. | 1994-03-11 | Traditional | PDF ↗ |
| K923530 | COULTER MULTI-Q-PREP | Coulter Electronics, Inc. | 1992-10-14 | Traditional | PDF ↗ |
| K904795 | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-31 | Traditional | PDF ↗ |
| K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | Toa Medical Electronics USA, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR | Abbott Diagnostics | 1985-07-05 | Traditional | PDF ↗ |
| K842747 | HYCEL DILUTOR, VARIOUS MODELS/MULTI | R&D Systems, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K842446 | DILU-MATIC 140 | Abbott Diagnostics | 1984-09-06 | Traditional | PDF ↗ |
| K823522 | DILULAB 230 | Innovative Medical Systems, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K791644 | ROYCO MODEL 371 SUPER DILUTOR | Royco Instruments | 1979-09-19 | Traditional | PDF ↗ |
| K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE | Ortho Diagnostics, Inc. | 1977-02-07 | Traditional | PDF ↗ |
Product code GKH · Class I · Hematology. Data: openFDA.