510(k) K871994 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
| Applicant | Behring Diagnostics, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Aug 12, 1987 |
| Received | May 26, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871994
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.