510(k) K940588 ยท LKO Anti-Rnp Antibody, Antigen And Control
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 20, 1994 |
| Received | Feb 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940588
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.