FDA product code GIA: Test, Leukocyte Peroxidase
GIA is the FDA product code for test, leukocyte peroxidase. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under GIA, from 2 different applicants. The average 510(k) review took 137 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Test, Leukocyte Peroxidase |
| Device class | Class I |
| Regulation | 21 CFR 864.7675 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GIA clearance
Top GIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 2 | 1985-01-04 |
| Techlab, Inc. | 1 | 1994-02-03 |
Most recent GIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931241 | Techlab, Inc. | FAST'N'FLAMMATORY KIT | 1994-02-03 | 329 |
| K844402 | Sigma Chemical Co. | SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR | 1985-01-04 | 52 |
| K811011 | Sigma Chemical Co. | HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE | 1981-05-15 | 30 |
Recalls for GIA devices
openFDA lists no recalls for product code GIA.
Frequently asked questions
What is FDA product code GIA?
GIA is the FDA product code for test, leukocyte peroxidase. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Pathology panel.
What device class is GIA?
Class I, regulation 21 CFR 864.7675. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIA?
Across 3 cleared submissions the average was 137 days from receipt to decision (median 52).
Which companies have the most GIA clearances?
Sigma Chemical Co. (2); Techlab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIA
- Run a recall and safety report across every GIA manufacturer
- Watch product code GIA 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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