GMD · Class II · 21 CFR 866.3165

FDA Product Code GMD: Antisera, Latex Agglutination, Cryptococcus Neoformans

Leading manufacturers include Immuno-Mycologics, Inc., Meridian Diagnostics, Inc. and Alexon Biomedical, Inc..

10
Total
10
Cleared
121d
Avg days
1978
Since

FDA 510(k) Cleared Antisera, Latex Agglutination, Cryptococcus Neoformans Devices (Product Code GMD)

10 devices
1–10 of 10
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422
Immuno-Mycologics, Inc.
Microbiology · 218d
Cleared Jul 20, 2011
CRAG LATERAL FLOW ASSAY (CRAG LFA)
K102286
Immuno-Mycologics, Inc.
Microbiology · 342d
Cleared Feb 17, 1994
CRYPTO-LEX SYSTEM
K930418
Trinity Laboratories, Inc.
Microbiology · 387d
Cleared Nov 22, 1993
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
K933997
Alexon Biomedical, Inc.
Microbiology · 97d
Cleared Sep 08, 1989
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Aug 31, 1981
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
K812188
American Scientific Products
Microbiology · 28d
Cleared Mar 20, 1981
YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
K810510
Immuno-Mycologics, Inc.
Microbiology · 24d
Cleared Jan 21, 1980
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Aug 16, 1979
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
K791382
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Apr 28, 1978
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526
I M, Inc.
Microbiology · 28d

About Product Code GMD - Regulatory Context