GSA — Antisera, All Mycoplasma Spp. Class I
FDA product code GSA covers "Antisera, All Mycoplasma Spp.", a Class I medical device regulated under 21 CFR 866.3375. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GSA
- 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 |
|---|---|---|---|
| K950073 | shared systems | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | October 17, 1995 |
| K910833 | seradyn | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | June 24, 1991 |
| K905493 | meridian diagnostics | MERISTAR-MP | January 30, 1991 |
| K903958 | intl. mycoplasma/mdc assoc | SEROFAST | December 21, 1990 |
| K883083 | medical diagnostic technologies | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | October 25, 1988 |
| K862630 | medical diagnostic technologies | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | September 3, 1986 |