JWT — Antigen, Cf, Aspergillus Spp. Class I
FDA product code JWT covers "Antigen, Cf, 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
- JWT
- 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 |
|---|---|---|---|
| K812740 | nolan biological laboratories | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | October 20, 1981 |
| K792700 | meridian diagnostics | ASPERGILLUS SP, COMPLEMENT FIXATION | January 17, 1980 |
| K791387 | immuno-mycologics | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | August 16, 1979 |
| K790672 | diagnostica | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | May 31, 1979 |
| K760830 | i m | ASPERGILLUS MYCELIAL ANTIGEN | November 1, 1976 |