GMD · Class II · 21 CFR 866.3165

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

Leading manufacturers include Meridian Diagnostics, Inc., I M, Inc. and Trinity Laboratories, 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 Feb 17, 1994
CRYPTO-LEX SYSTEM
K930418
Trinity Laboratories, Inc.
Microbiology · 387d
Cleared Sep 08, 1989
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 21, 1980
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Apr 28, 1978
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526
I M, Inc.
Microbiology · 28d

About Product Code GMD - Regulatory Context