Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126
Total
126
Cleared
0
Denied
54 devices
Cleared
Mar 15, 1990
ORTHOKROME* FACTOR VIII
Hematology
45d
Cleared
Mar 15, 1990
ORTHOKROME* HEPARIN
Hematology
45d
Cleared
Mar 15, 1990
ORTHOKROME* ANTIPLASMIN
Hematology
45d
Cleared
Mar 15, 1990
ORTHOKROME* PROTEIN C
Hematology
45d
Cleared
Mar 15, 1990
ORTHOKROME* PLASMINOGEN
Hematology
45d
Cleared
Mar 15, 1990
ORTHOKROME* ANTITHROMBIN
Hematology
45d
Cleared
Feb 03, 1989
KOAGULAB* 32-S COAGULATION SYSTEM
Hematology
60d
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
Jul 21, 1986
KOAGULAB* M COAGULATION SYSTEM
Hematology
19d
Cleared
Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
Hematology
89d
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
Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
Hematology
96d
Cleared
Jan 13, 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
Hematology
91d
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
Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
Hematology
45d
Cleared
Jul 14, 1982
ORTHO SPECTRUM III & ORTHO-MUNE OK
Hematology
128d
Cleared
May 12, 1982
FETALSCREEN
Hematology
106d
Cleared
Mar 15, 1982
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
Hematology
31d
Cleared
Oct 28, 1981
ELUAID
Hematology
106d