510(k) K983420 ยท LKP Anti-Sm Antibody, Antigen And Control
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983420
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.