510(k) K012359 ยท DBI Complement C4, Antigen, Antiserum, Control
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 29, 2001 |
| Received | Jul 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2020 | Roche Diagnostics Operations, Inc. Tina-quant Complement C4 ver.2, Catalog 05991994190 Terminated |
DBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.