JWW — Antigen, Cf, B. Dermatitidis Class II
FDA product code JWW covers "Antigen, Cf, B. Dermatitidis", a Class II medical device regulated under 21 CFR 866.3060. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JWW
- Device Class
- Class II
- Regulation Number
- 866.3060
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K802128 | nolan biological laboratories | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | September 26, 1980 |
| K792683 | meridian diagnostics | BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION | January 23, 1980 |
| K792680 | meridian diagnostics | BLASTOMYCES DERMATITIDIS, ANTIGEN | January 17, 1980 |