GSB
5 FDA 510(k) clearances · Product code
42 daysmedian time to decision
81 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antigens, Cf, 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 SPP SEROLOGICAL REAGENTS (K852933) | Microbix Biosystems, Inc. | 1985-08-01 |
| MYCOPLASMA PNEUMONIAE (K843664) | Institute Virion , Ltd. | 1984-10-25 |
| MYCOPLASMA PNEUMONIAE CF ANTIGEN (K834338) | Hillcrest Biologicals | 1984-02-27 |
| SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132) | Miles Laboratories, Inc. | 1983-09-20 |
| MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (K802934) | Orion Diagnostica, Inc. | 1980-12-31 |
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Every clearance here is in the API, with alerts when new ones post.