Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126
Total
126
Cleared
0
Denied
126 devices
Cleared
Sep 12, 1985
ORTHO DNA PROBE HSV CONFIRMATION TEST
Microbiology
100d
Cleared
Aug 28, 1985
ORTHO VIRAL TRANSPORT
Microbiology
8d
Cleared
Aug 08, 1985
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
Hematology
37d
Cleared
Jul 23, 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
Hematology
95d
Cleared
Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
Microbiology
239d
Cleared
Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
Hematology
96d
Cleared
Oct 05, 1984
ORTHO* RSV ANTIGEN ELISA TEST SYS
Microbiology
137d
Cleared
Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
Microbiology
122d
Cleared
Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
Microbiology
74d
Cleared
Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
Immunology
240d
Cleared
May 22, 1984
ORTHO MICROWELL READER
Chemistry
36d
Cleared
May 21, 1984
RUBELLA IGG ANTIBODY ELISA TEST SYS
Microbiology
61d
Cleared
May 02, 1984
HSV ANTIGEN ELISA KIT
Microbiology
135d
Cleared
Mar 23, 1984
ORTHO BI-LEVEL RECEPTOR CONTROL
Chemistry
119d
Cleared
Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
Immunology
130d
Cleared
Jan 18, 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
Chemistry
126d
Cleared
Jan 13, 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
Hematology
91d
Cleared
Sep 29, 1983
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO
Pathology
29d
Cleared
Aug 24, 1983
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
Chemistry
93d
Cleared
Aug 12, 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
Hematology
35d
Cleared
Jul 26, 1983
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
Hematology
98d
Cleared
Jun 30, 1983
TRI-LEVEL TDM CONTROL & I II III
Toxicology
50d
Cleared
Mar 17, 1983
ORTHO RUBELLA ELISA TEST SYSTEM
Microbiology
225d
Cleared
Feb 28, 1983
MANUALISA MICROTITRATION PLATE READER
Chemistry
84d
Cleared
Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
Chemistry
43d
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