510(k) K853399 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
VIROGEN ROTATEST SLIDE TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Nov 12, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853399
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.