FDA product code GHD: Test, Leukocyte Alkaline Phosphatase
GHD is the FDA product code for test, leukocyte alkaline phosphatase. It is a Class I device, regulated under 21 CFR 864.7660 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GHD, from 2 different applicants. The average 510(k) review took 82 days (median 98).
Classification
| Field | Value |
|---|---|
| Device name | Test, Leukocyte Alkaline Phosphatase |
| Device class | Class I |
| Regulation | 21 CFR 864.7660 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GHD clearance
Top GHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 3 | 1990-12-18 |
| Biodynamics Corp. | 1 | 1981-07-27 |
Most recent GHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904022 | Sigma Chemical Co. | NITRO BLUE TETRAZOLIUM REDUCTION | 1990-12-18 | 110 |
| K903995 | Sigma Chemical Co. | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | 1990-12-13 | 106 |
| K896092 | Sigma Chemical Co. | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | 1989-11-09 | 21 |
| K811189 | Biodynamics Corp. | CHEMSTRIP L | 1981-07-27 | 89 |
Recalls for GHD devices
openFDA lists no recalls for product code GHD.
Frequently asked questions
What is FDA product code GHD?
GHD is the FDA product code for test, leukocyte alkaline phosphatase. It is a Class I device, regulated under 21 CFR 864.7660 and reviewed by the Hematology panel.
What device class is GHD?
Class I, regulation 21 CFR 864.7660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GHD?
Across 4 cleared submissions the average was 82 days from receipt to decision (median 98).
Which companies have the most GHD clearances?
Sigma Chemical Co. (3); Biodynamics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GHD
- Run a recall and safety report across every GHD manufacturer
- Watch product code GHD 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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