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
54 devices
51-54 of 54
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 Feb 26, 1981
ORTHO QUANTITATIVE FIBRINOGEN ASSAY
K810058 · KQJ
Hematology · 44d
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