510(k) K012163 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
POLYTITER SYSTEM
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012163
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.