FDA product code GTR: Antideoxyribonuclease, Streptococcus Spp.
GTR is the FDA product code for antideoxyribonuclease, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GTR. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Antideoxyribonuclease, Streptococcus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3720 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top GTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Calbiochem-Behring Corp. | 1 | 1979-07-24 |
Most recent GTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790997 | Calbiochem-Behring Corp. | ANTI-DNASE B REAGENT SYSTEM | 1979-07-24 | 56 |
Recalls for GTR devices
openFDA lists no recalls for product code GTR.
Frequently asked questions
What is FDA product code GTR?
GTR is the FDA product code for antideoxyribonuclease, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel.
What device class is GTR?
Class I, regulation 21 CFR 866.3720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTR?
Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most GTR clearances?
Calbiochem-Behring Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTR
- Run a recall and safety report across every GTR manufacturer
- Watch product code GTR 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.