Apparatus, Automated Blood Cell Diluting
Apparatus, Automated Blood Cell Diluting (product code GKH) is a laboratory instrument used to automatically prepare precise dilutions of whole blood samples for subsequent cell counting or analysis in hematology, reducing manual pipetting error and improving throughput. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.5240 in the Hematology specialty (HE), this device carries no special regulatory flags.
Research product code GKH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GKH
- Device Class
- FDA class 1
- Regulation Number
- 864.5240
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Aug 26, 2010 | Substantially Equivalent | Veridex, LLC |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Mar 12, 2004 | Substantially Equivalent | Immunicon Corp. |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Sep 30, 2002 | Substantially Equivalent | Immunicon Corp. |
| K021150 | COULTER CELLPREP | Jun 11, 2002 | Substantially Equivalent | Beckman Coulter, Inc. |
| K935953 | COULTER MULTI Q PREP | Mar 11, 1994 | Substantially Equivalent | Coulter Corp. |
| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent | Coulter Electronics, Inc. |
| K904795 | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Dec 31, 1990 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | Jul 18, 1988 | Substantially Equivalent | Toa Medical Electronics USA, Inc. |
| K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR | Jul 05, 1985 | Substantially Equivalent | Abbott Diagnostics |
| K842747 | HYCEL DILUTOR, VARIOUS MODELS/MULTI | Oct 01, 1984 | Substantially Equivalent | R&D Systems, Inc. |
| K842446 | DILU-MATIC 140 | Sep 06, 1984 | Substantially Equivalent | Abbott Diagnostics |
| K823522 | DILULAB 230 | Dec 28, 1982 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K791644 | ROYCO MODEL 371 SUPER DILUTOR | Sep 19, 1979 | Substantially Equivalent | Royco Instruments |
| K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE | Feb 07, 1977 | Substantially Equivalent | Ortho Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.