510(k) K915551 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
ORTHO HSV ANTIGEN ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Apr 22, 1992 |
| Received | Dec 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915551
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.