Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126
Total
126
Cleared
0
Denied
126 devices
Cleared
Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
Hematology
45d
Cleared
Oct 08, 1982
ACUSCREEN
Chemistry
24d
Cleared
Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
Immunology
58d
Cleared
Aug 27, 1982
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
Toxicology
52d
Cleared
Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
Chemistry
119d
Cleared
Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
Immunology
18d
Cleared
Jul 14, 1982
ORTHO SPECTRUM III & ORTHO-MUNE OK
Hematology
128d
Cleared
Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
Immunology
8d
Cleared
May 12, 1982
FETALSCREEN
Hematology
106d
Cleared
Mar 15, 1982
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
Hematology
31d
Cleared
Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
Chemistry
22d
Cleared
Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
Chemistry
17d
Cleared
Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
Chemistry
24d
Cleared
Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
Chemistry
24d
Cleared
Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
Chemistry
24d
Cleared
Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
Chemistry
23d
Cleared
Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
Chemistry
23d
Cleared
Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
Chemistry
12d
Cleared
Oct 28, 1981
ELUAID
Hematology
106d
Cleared
Oct 23, 1981
AVI-D CONTROL
Hematology
128d
Cleared
Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
Hematology
104d
Cleared
Jul 27, 1981
ORTHO SICKLE CELL CONTROLS
Hematology
26d
Cleared
Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
Chemistry
17d
Cleared
Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
Chemistry
17d
Cleared
Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
Chemistry
17d
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