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

73 devices

26-50 of 73

Cleared Jul 30, 1992

PERMIER HISTOPLASMA

Microbiology · 220d

Cleared Jul 10, 1992

PREMIER COCCIDIOIDES

Microbiology · 214d

Cleared Jul 24, 1991

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA

Microbiology · 54d

Cleared Jan 30, 1991

Microbiology · 54d

Cleared Jan 25, 1991

PREMIER-CRYPTOCOCCAL ANTIGEN

Microbiology · 122d

Cleared Oct 16, 1990

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

Microbiology · 25d

Cleared Mar 12, 1990

MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM

Microbiology · 153d

Cleared Sep 08, 1989

(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE

Microbiology · 28d

Cleared Aug 15, 1989

MERIVIEW TM TRICHOMONAS

Microbiology · 55d

Cleared May 24, 1989

MERIFLUOR(TM) -TRICHOMONAS

Microbiology · 50d

Cleared Aug 04, 1988

MERIFLUOR(TM) PNEUMOCYSTIS

Microbiology · 114d

Cleared Apr 12, 1988

MERITEC(TM)-CAMPY (JCL)

Microbiology · 75d

Cleared Dec 09, 1987

Microbiology · 64d

Cleared Sep 16, 1987

MERIFLUOR(TM)-GIARDIA

Microbiology · 29d

Cleared Mar 16, 1987

(MERIFLUOR)TM-CRYPTOSPORIDIUM

Microbiology · 61d

Cleared Feb 21, 1986

PARA-PAK MACRO-CON

Microbiology · 46d

Cleared Jul 18, 1985

MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE

Microbiology · 176d

Cleared Aug 11, 1983

MERITEC-STREP GROUP A BETA-HEMOLYTIC

Microbiology · 86d

Cleared May 13, 1982

MERITECASTREP (TM)

Microbiology · 23d

Cleared Apr 14, 1982

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT

Microbiology · 43d

Cleared Jun 16, 1981

Microbiology · 32d

Cleared Mar 19, 1980

SMITH'S SYSTEMIC FUNGAL MEDIUM

Microbiology · 83d

Cleared Jan 24, 1980

NEGATIVE CONTROL SERUM

Microbiology · 28d

Cleared Jan 24, 1980

CANDIDA ALBICANS, ANTIGEN

Microbiology · 28d

Cleared Jan 23, 1980

BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

Microbiology · 27d