510(k) K893897 ยท LKJ Antinuclear Antibody, Antigen, Control
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
| Applicant | Biostar Medical Products, Inc., Arlington VA, US |
| Decision | Substantially Equivalent, Jun 23, 1989 |
| Received | May 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893897
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.