FDA product code GKH: Apparatus, Automated Blood Cell Diluting
GKH is the FDA product code for apparatus, automated blood cell diluting. It is a Class I device, regulated under 21 CFR 864.5240 and reviewed by the Hematology panel. FDA has cleared 14 510(k) submissions under GKH, from 12 different applicants. The average 510(k) review took 67 days (median 68). FDA has posted 2 recalls for GKH devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Automated Blood Cell Diluting |
| Device class | Class I |
| Regulation | 21 CFR 864.5240 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GKH clearance
Top GKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunicon Corp. | 2 | 2004-03-12 |
| Abbott Diagnostics | 2 | 1985-07-05 |
| Veridex, LLC | 1 | 2010-08-26 |
| Beckman Coulter, Inc. | 1 | 2002-06-11 |
| Coulter Corp. | 1 | 1994-03-11 |
7 more applicants have GKH clearances. See the full list in Caduvo.
Most recent GKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100684 | Veridex, LLC | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | 2010-08-26 | 169 |
| K040077 | Immunicon Corp. | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | 2004-03-12 | 58 |
| K022512 | Immunicon Corp. | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | 2002-09-30 | 62 |
| K021150 | Beckman Coulter, Inc. | COULTER CELLPREP | 2002-06-11 | 62 |
| K935953 | Coulter Corp. | COULTER MULTI Q PREP | 1994-03-11 | 88 |
Recalls for GKH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-19.
Frequently asked questions
What is FDA product code GKH?
GKH is the FDA product code for apparatus, automated blood cell diluting. It is a Class I device, regulated under 21 CFR 864.5240 and reviewed by the Hematology panel.
What device class is GKH?
Class I, regulation 21 CFR 864.5240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GKH?
Across 14 cleared submissions the average was 67 days from receipt to decision (median 68).
Which companies have the most GKH clearances?
Immunicon Corp. (2); Abbott Diagnostics (2); Veridex, LLC (1); Beckman Coulter, Inc. (1); Coulter Corp. (1).
Have GKH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GKH
- Run a recall and safety report across every GKH manufacturer
- Watch product code GKH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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