510(k) K971585 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
IMMUNOCARD STAT! ROTAVIRUS
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Aug 20, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2022 | MEDLINE INDUSTRIES, LP - Northfield meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box.
The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus Terminated |
LIQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.