510(k) K852969 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
| Applicant | Cambridge Bioscience Corp., Hopkinton MA, US |
| Decision | Substantially Equivalent, Nov 5, 1985 |
| Received | Jul 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852969
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2021 | MEDLINE INDUSTRIES, LP - Northfield Premier Rotaclone, Rx only Terminated |
LIQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.