Ortho Diagnostic Systems, Inc.

Ortho Diagnostic Systems, Inc. — FDA 510(k) Submissions

Ortho Diagnostic Systems, Inc. has submitted 126 FDA 510(k) premarket notifications since 1981, of which 126 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Multi-analyte Controls, All Kinds (assayed), System, Multipurpose For In Vitro Coagulation Studies, Enzyme Linked Immunoabsorbent Assay, Rubella, Plasma, Coagulation Factor Deficient . Use the specialty filter in the sidebar to narrow results.