510(k) K993971 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
| Applicant | Micro Detect, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Jan 11, 2000 |
| Received | Nov 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993971
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.