510(k) K040435 ยท CZP Iga, Antigen, Antiserum, Control
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Feb 19, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2019 | Roche Diagnostics Corporation The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. Terminated |
CZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.