Medical Device Manufacturer · US , Walker , MI

Meridian Diagnostics, Inc. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 1980
92
Total
92
Cleared
0
Denied
92 devices
26-50 of 92
Cleared Oct 19, 1992
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · LLH
Chemistry · 62d
Cleared Oct 05, 1992
PREMIER BLASTOMYCES
K923859 · MJL
Microbiology · 66d
Cleared Jul 30, 1992
PERMIER HISTOPLASMA
K915700 · MIZ
Microbiology · 220d
Cleared Jul 10, 1992
PREMIER COCCIDIOIDES
K915493 · MIY
Microbiology · 214d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408 · MHI
Microbiology · 54d
Cleared Jan 30, 1991
MERISTAR-MP
K905493 · GSA
Microbiology · 54d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393 · MDU
Microbiology · 122d
Cleared Oct 16, 1990
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · LYF
Microbiology · 25d
Cleared Oct 01, 1990
PREMIER-C. DIFFICILE TOXIN A
K903456 · LLH
Toxicology · 61d
Cleared Mar 12, 1990
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · MCB
Microbiology · 153d
Cleared Sep 08, 1989
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · GMD
Microbiology · 28d
Cleared Aug 15, 1989
MERIVIEW TM TRICHOMONAS
K894246 · JWZ
Microbiology · 55d
Cleared May 24, 1989
MERIFLUOR(TM) -TRICHOMONAS
K892263 · JWZ
Microbiology · 50d
Cleared Aug 04, 1988
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · LYF
Microbiology · 114d
Cleared Apr 12, 1988
MERITEC(TM)-CAMPY (JCL)
K880389 · LQP
Microbiology · 75d
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078 · LIC
Microbiology · 64d
Cleared Sep 16, 1987
MERIFLUOR(TM)-GIARDIA
K873299 · GWD
Microbiology · 29d
Cleared Mar 16, 1987
(MERIFLUOR)TM-CRYPTOSPORIDIUM
K870171
Microbiology · 61d
Cleared Feb 21, 1986
PARA-PAK MACRO-CON
K860034 · LKS
Microbiology · 46d
Cleared Jul 18, 1985
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE
K850269 · LIQ
Microbiology · 176d
Cleared Aug 11, 1983
MERITEC-STREP GROUP A BETA-HEMOLYTIC
K831599 · GTY
Microbiology · 86d
Cleared May 13, 1982
MERITECASTREP (TM)
K821100 · GTZ
Microbiology · 23d
Cleared Apr 14, 1982
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
K820531 · LHT
Microbiology · 43d
Cleared Nov 10, 1981
NEUTRAL DUFFERED FORMA-SCENT
K812817 · IFP
Pathology · 34d
Cleared Jul 15, 1981
PARA-PAK
K811722 · HYI
Toxicology · 27d

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