510(k) K983541 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
HSV 1+2 IGG ELISA TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Oct 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983541
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.