GSB — Antigens, Cf, All, Mycoplasma Spp. Class I
FDA product code GSB covers "Antigens, Cf, All, Mycoplasma Spp.", a Class I medical device regulated under 21 CFR 866.3375. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GSB
- Device Class
- Class I
- Regulation Number
- 866.3375
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K852933 | microbix biosystems | MYCOPLASMA SPP SEROLOGICAL REAGENTS | August 1, 1985 |
| K843664 | institute virion | MYCOPLASMA PNEUMONIAE | October 25, 1984 |
| K834338 | hillcrest biologicals | MYCOPLASMA PNEUMONIAE CF ANTIGEN | February 27, 1984 |
| K832132 | miles laboratories | SERA-TEK MYCOPLASMA ANTIBODY TEST | September 20, 1983 |
| K802934 | orion diagnostica | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | December 31, 1980 |