510(k) K931543 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENCORE ENA COMBINED EIA
| Applicant | Clark Laboratories, Inc., Blairstown NJ, US |
| Decision | Substantially Equivalent, Sep 8, 1993 |
| Received | Mar 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931543
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.