510(k) K964165 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
MICRO21 WITH NDNA
| Applicant | Triangle Biomedical Sciences, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 3, 1997 |
| Received | Oct 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964165
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.