Panels › Microbiology › Product code GMD · Class 2
Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation 866.3165
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GMD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2012 | K112422 | CRAG LATERAL FLOW ASSAY (LFA) Immuno-Mycologics, Inc. | GMD |
| Jul 20, 2011 | K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) Immuno-Mycologics, Inc. | GMD |
| Feb 17, 1994 | K930418 | CRYPTO-LEX SYSTEM Trinity Laboratories, Inc. | GMD |
| Nov 22, 1993 | K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY Alexon Biomedical, Inc. | GMD |
| Sep 8, 1989 | K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE Meridian Diagnostics, Inc. | GMD |
| Aug 31, 1981 | K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI American Scientific Products | GMD |
| Mar 20, 1981 | K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION Immuno-Mycologics, Inc. | GMD |
| Jan 21, 1980 | K792693 | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX Meridian Diagnostics, Inc. | GMD |
| Aug 16, 1979 | K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION Immuno-Mycologics, Inc. | GMD |
| Apr 28, 1978 | K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM I M, Inc. | GMD |
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