GSA
6 FDA 510(k) clearances · Product code
115 daysmedian time to decision
281 days90th percentile
6clearances measured
FDA profile
- Official device name
- Antisera, All Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (K950073) | Shared Systems, Inc. | 1995-10-17 |
| COLOR VUE TM- MYCOPLASMA PNEUMONIAE (K910833) | Seradyn, Inc. | 1991-06-24 |
| MERISTAR-MP (K905493) | Meridian Diagnostics, Inc. | 1991-01-30 |
| SEROFAST (K903958) | Intl. Mycoplasma/Mdc Assoc. | 1990-12-21 |
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K883083) | Medical Diagnostic Technologies, Inc. | 1988-10-25 |
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K862630) | Medical Diagnostic Technologies, Inc. | 1986-09-03 |
Track GSA automatically
Every clearance here is in the API, with alerts when new ones post.