KFG
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
273 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antiserum, Positive Control, Aspergillus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3040
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (K904499) | Ackrad Laboratories | 1991-07-01 |
| ASPERGILLUS SP, ANTISERUM POSITIVE (K792686) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ASPERGILLUS SP, ANTISERUM, POSITIVE (K792698) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM (K791386) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) (K760835) | I M, Inc. | 1976-11-01 |
Track KFG automatically
Every clearance here is in the API, with alerts when new ones post.