510(k) K990916 ยท KTL Anti-Dna Indirect Immunofluorescent Solid Phase
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
| Applicant | Stellar Bio Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Apr 21, 1999 |
| Received | Mar 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990916
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.