GKH — Apparatus, Automated Blood Cell Diluting Class I
FDA product code GKH covers "Apparatus, Automated Blood Cell Diluting", a Class I medical device regulated under 21 CFR 864.5240. Submissions are reviewed by the Hematology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKH
- Device Class
- Class I
- Regulation Number
- 864.5240
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100684 | veridex | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | August 26, 2010 |
| K040077 | immunicon | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | March 12, 2004 |
| K022512 | immunicon | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | September 30, 2002 |
| K021150 | beckman coulter | COULTER CELLPREP | June 11, 2002 |
| K935953 | coulter | COULTER MULTI Q PREP | March 11, 1994 |
| K923530 | coulter electronics | COULTER MULTI-Q-PREP | October 14, 1992 |
| K904795 | bd becton dickinson vacutainer systems preanalytic | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | December 31, 1990 |
| K882767 | toa medical electronics usa | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | July 18, 1988 |
| K852373 | abbott diagnostics | AD150, AUTOMATED HEMATOLOGY DILUTOR | July 5, 1985 |
| K842747 | r and d systems | HYCEL DILUTOR, VARIOUS MODELS/MULTI | October 1, 1984 |
| K842446 | abbott diagnostics | DILU-MATIC 140 | September 6, 1984 |
| K823522 | innovative medical systems | DILULAB 230 | December 28, 1982 |
| K791644 | royco instruments | ROYCO MODEL 371 SUPER DILUTOR | September 19, 1979 |
| K761137 | ortho diagnostics | MICROSAMPLE BLOOD COLLECTION DEVICE | February 7, 1977 |