510(k) K023556 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
FLU OIA A/B TEST KIT
| Applicant | Thermo Biostar, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 27, 2003 |
| Received | Oct 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2008 | Inverness Medical BioStar Inc. BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 Terminated |
GNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.