510(k) K941046 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
VZV IGG ELISA TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 24, 1995 |
| Received | Mar 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941046
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.