Orion Diagnostica, Inc. - FDA 510(k) Cleared Devices
Recent clearances: DIARLEX ROTA-ADENO, SALIVA-STIM, PYLORISET
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orion Diagnostica, Inc. Immunology ✕
5 devices
Cleared
Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
Immunology
30d
Cleared
Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
Immunology
23d
Cleared
Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
Immunology
22d
Cleared
May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
Immunology
43d
Cleared
Jan 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
Immunology
56d