Medical Device Manufacturer · US , Westwood , MA

Pb Diagnostics, Inc.

4 submissions · 4 cleared · Since 1991
4
Total
4
Cleared
0
Denied

Pb Diagnostics, Inc. — FDA 510(k) Submissions

Pb Diagnostics, Inc. has submitted 4 FDA 510(k) premarket notifications since 1991, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Serological, Positive Control, Antibody Igm,if, Cytomegalovirus Virus, Enzyme Linked Immunoabsorbent Assay, Rubella, Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
Filters