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. Immunology ✕
5 devices
Cleared
Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
Immunology
240d
Cleared
Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
Immunology
130d
Cleared
Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
Immunology
58d
Cleared
Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
Immunology
18d
Cleared
Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
Immunology
8d