FDA product code GKX: Instrument, Automated Platelet Counting
GKX is the FDA product code for instrument, automated platelet counting. It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GKX, from 2 different applicants. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Automated Platelet Counting |
| Device class | Class II |
| Regulation | 21 CFR 864.5200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GKX clearance
Top GKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abx Diagnostics | 1 | 2002-02-28 |
| Gainor Medical | 1 | 1984-08-14 |
Most recent GKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K014203 | Abx Diagnostics | ABX MICROS 60 HEMATOLOGY ANALYZER | 2002-02-28 | 69 |
| K840948 | Gainor Medical | CLEAR POROUS PLASTIC-HYPOALLERGENIC | 1984-08-14 | 39 |
Recalls for GKX devices
openFDA lists no recalls for product code GKX.
Frequently asked questions
What is FDA product code GKX?
GKX is the FDA product code for instrument, automated platelet counting. It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel.
What device class is GKX?
Class II, regulation 21 CFR 864.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKX?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most GKX clearances?
Abx Diagnostics (1); Gainor Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GKX
- Run a recall and safety report across every GKX manufacturer
- Watch product code GKX 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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