GTR — Antideoxyribonuclease, Streptococcus Spp. Class I
FDA product code GTR covers "Antideoxyribonuclease, Streptococcus Spp.", a Class I medical device regulated under 21 CFR 866.3720. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GTR
- Device Class
- Class I
- Regulation Number
- 866.3720
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K790997 | calbiochem-behring | ANTI-DNASE B REAGENT SYSTEM | July 24, 1979 |