GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans Class II
FDA product code GMD covers "Antisera, Latex Agglutination, Cryptococcus Neoformans", a Class II medical device regulated under 21 CFR 866.3165. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMD
- Device Class
- Class II
- Regulation Number
- 866.3165
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K112422 | immuno-mycologics | CRAG LATERAL FLOW ASSAY (LFA) | March 28, 2012 |
| K102286 | immuno-mycologics | CRAG LATERAL FLOW ASSAY (CRAG LFA) | July 20, 2011 |
| K930418 | trinity laboratories | CRYPTO-LEX SYSTEM | February 17, 1994 |
| K933997 | alexon biomedical | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | November 22, 1993 |
| K894845 | meridian diagnostics | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | September 8, 1989 |
| K812188 | american scientific products | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | August 31, 1981 |
| K810510 | immuno-mycologics | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | March 20, 1981 |
| K792693 | meridian diagnostics | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX | January 21, 1980 |
| K791382 | immuno-mycologics | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | August 16, 1979 |
| K780526 | i m | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | April 28, 1978 |