510(k) K853554 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
| Applicant | Kallestad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 26, 1985 |
| Received | Aug 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853554
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.