510(k) K981306 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Sep 29, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981306
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.