510(k) K000312 ยท LKP Anti-Sm Antibody, Antigen And Control
VARELISA SM ANTIBODIES
| Applicant | Pharmacia & Upjohn Co., Westervillle OH, US |
| Decision | Substantially Equivalent, Mar 17, 2000 |
| Received | Feb 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000312
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.