510(k) K802527 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
TEST KIT FOR DETECTION OF ANTINUCLEAR
| Applicant | Bartels & Stout, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Jan 5, 1981 |
| Received | Oct 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802527
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.