KFG — Antiserum, Positive Control, Aspergillus Spp. Class I
FDA product code KFG covers "Antiserum, Positive Control, Aspergillus Spp.", a Class I medical device regulated under 21 CFR 866.3040. 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
- KFG
- Device Class
- Class I
- Regulation Number
- 866.3040
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K904499 | ackrad laboratories | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | July 1, 1991 |
| K792686 | meridian diagnostics | ASPERGILLUS SP, ANTISERUM POSITIVE | January 17, 1980 |
| K792698 | meridian diagnostics | ASPERGILLUS SP, ANTISERUM, POSITIVE | January 17, 1980 |
| K791386 | immuno-mycologics | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | August 16, 1979 |
| K760835 | i m | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | November 1, 1976 |