Medical Device Manufacturer · US , Carpinteria , CA

Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

126 submissions · 126 cleared · Since 1981
126
Total
126
Cleared
0
Denied
126 devices
101-125 of 126
Cleared Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · KQG
Hematology · 45d
Cleared Oct 08, 1982
ACUSCREEN
K822782 · GGW
Chemistry · 24d
Cleared Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · DAK
Immunology · 58d
Cleared Aug 27, 1982
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
K821975 · DIF
Toxicology · 52d
Cleared Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · JJY
Chemistry · 119d
Cleared Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898 · DBA
Immunology · 18d
Cleared Jul 14, 1982
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · LIZ
Hematology · 128d
Cleared Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806 · DAK
Immunology · 8d
Cleared May 12, 1982
FETALSCREEN
K820199
Hematology · 106d
Cleared Mar 15, 1982
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
K820400 · JPK
Hematology · 31d
Cleared Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392 · LAS
Chemistry · 22d
Cleared Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255 · JJY
Chemistry · 17d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293 · JJY
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · JJY
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · JJY
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321 · JJY
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322 · JJY
Chemistry · 23d
Cleared Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · JJY
Chemistry · 12d
Cleared Oct 28, 1981
ELUAID
K812002 · GGK
Hematology · 106d
Cleared Oct 23, 1981
AVI-D CONTROL
K811713 · KSF
Hematology · 128d
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · LCP
Hematology · 104d
Cleared Jul 27, 1981
ORTHO SICKLE CELL CONTROLS
K811894 · GKA
Hematology · 26d
Cleared Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · JJY
Chemistry · 17d
Cleared Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466 · JJY
Chemistry · 17d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · JJY
Chemistry · 17d

Looking for a specific device from Ortho Diagnostic Systems, Inc.? Search by device name or K-number.

Search all Ortho Diagnostic... devices
Filters