510(k) K963645 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
HERPES GROUP IGG ELISA TEST SYSTEM
| Applicant | Armkel, LLC, Frederick MD, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Sep 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963645
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.