FDA product code GKM: Hand-Tally, Differential
GKM is the FDA product code for hand-tally, differential. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GKM, from 4 different applicants. The average 510(k) review took 68 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Hand-Tally, Differential |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GKM clearance
Top GKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coulter Electronics, Inc. | 1 | 1988-01-19 |
| Future Impex Corp. | 1 | 1986-04-04 |
| Instrumentation Laboratory CO | 1 | 1984-04-04 |
| Scientific Products | 1 | 1977-09-02 |
Most recent GKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874188 | Coulter Electronics, Inc. | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | 1988-01-19 | 97 |
| K854685 | Future Impex Corp. | DIGITAL-9 KEY LEUCOCYTE COUNTER | 1986-04-04 | 135 |
| K841026 | Instrumentation Laboratory CO | MANUAL BLOOD CELL COUNTING DEVICE | 1984-04-04 | 23 |
| K771580 | Scientific Products | TEKTALLY II | 1977-09-02 | 15 |
Recalls for GKM devices
openFDA lists no recalls for product code GKM.
Frequently asked questions
What is FDA product code GKM?
GKM is the FDA product code for hand-tally, differential. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GKM?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GKM?
Across 4 cleared submissions the average was 68 days from receipt to decision (median 60).
Which companies have the most GKM clearances?
Coulter Electronics, Inc. (1); Future Impex Corp. (1); Instrumentation Laboratory CO (1); Scientific Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GKM
- Run a recall and safety report across every GKM manufacturer
- Watch product code GKM 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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