Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE, ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE), ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
126
Total
126
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho Diagnostic Systems, Inc. Chemistry ✕
22 devices
Cleared
May 16, 1995
ORTHO ALT MICROWELL TEST SYSTEM
Chemistry
428d
Cleared
Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
Chemistry
79d
Cleared
Oct 20, 1987
RESULT PLUS/HCG PREGNANCY TEST
Chemistry
104d
Cleared
May 22, 1984
ORTHO MICROWELL READER
Chemistry
36d
Cleared
Mar 23, 1984
ORTHO BI-LEVEL RECEPTOR CONTROL
Chemistry
119d
Cleared
Jan 18, 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
Chemistry
126d
Cleared
Aug 24, 1983
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
Chemistry
93d
Cleared
Feb 28, 1983
MANUALISA MICROTITRATION PLATE READER
Chemistry
84d
Cleared
Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
Chemistry
43d
Cleared
Oct 08, 1982
ACUSCREEN
Chemistry
24d
Cleared
Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
Chemistry
119d
Cleared
Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
Chemistry
22d