Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126
Total
126
Cleared
0
Denied
126 devices
Cleared
Feb 07, 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
Microbiology
141d
Cleared
Feb 03, 1989
KOAGULAB* 32-S COAGULATION SYSTEM
Hematology
60d
Cleared
Feb 02, 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
Microbiology
90d
Cleared
Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
Microbiology
107d
Cleared
Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
Microbiology
107d
Cleared
Dec 22, 1988
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
Microbiology
94d
Cleared
Dec 22, 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
Microbiology
94d
Cleared
Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
Hematology
64d
Cleared
Nov 01, 1988
ORTHO OWREN'S BUFFER
Hematology
64d
Cleared
Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
Hematology
64d
Cleared
Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
Hematology
64d
Cleared
Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
Hematology
64d
Cleared
Oct 06, 1988
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
Microbiology
17d
Cleared
Aug 01, 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
Microbiology
83d
Cleared
May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
Microbiology
319d
Cleared
Apr 27, 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
Microbiology
16d
Cleared
Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
Obstetrics & Gynecology
42d
Cleared
Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
Microbiology
168d
Cleared
Oct 20, 1987
RESULT PLUS/HCG PREGNANCY TEST
Chemistry
104d
Cleared
Jun 26, 1987
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
Obstetrics & Gynecology
65d
Cleared
Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
Microbiology
57d
Cleared
Jul 21, 1986
KOAGULAB* M COAGULATION SYSTEM
Hematology
19d
Cleared
Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
Microbiology
88d
Cleared
Dec 06, 1985
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
Microbiology
91d
Cleared
Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
Hematology
89d
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