FDA product code GTP: Exoenzymes, Multiple, Streptococcal
GTP is the FDA product code for exoenzymes, multiple, streptococcal. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GTP, from 3 different applicants. The average 510(k) review took 58 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Exoenzymes, Multiple, Streptococcal |
| Device class | Class I |
| Regulation | 21 CFR 866.3720 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GTP clearance
Top GTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio Spec, Inc. | 1 | 1986-01-24 |
| Cooper Biomedical, Inc. | 1 | 1983-12-27 |
| American Scientific Products | 1 | 1982-12-19 |
Most recent GTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860041 | Bio Spec, Inc. | STREP D FLUOR | 1986-01-24 | 18 |
| K833738 | Cooper Biomedical, Inc. | LEAP STREP TEST KIT | 1983-12-27 | 63 |
| K822799 | American Scientific Products | STREPTACOCCUS CO-AGGLUTINATION KIT | 1982-12-19 | 94 |
Recalls for GTP devices
openFDA lists no recalls for product code GTP.
Frequently asked questions
What is FDA product code GTP?
GTP is the FDA product code for exoenzymes, multiple, streptococcal. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel.
What device class is GTP?
Class I, regulation 21 CFR 866.3720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTP?
Across 3 cleared submissions the average was 58 days from receipt to decision (median 63).
Which companies have the most GTP clearances?
Bio Spec, Inc. (1); Cooper Biomedical, Inc. (1); American Scientific Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTP
- Run a recall and safety report across every GTP manufacturer
- Watch product code GTP 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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