510(k) K831036 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENA TEST KIT SM & RNP AUTO ANTIBODY
| Applicant | Calbiochem-Behring Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 27, 1983 |
| Received | Mar 31, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831036
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.