510(k) K040431 ยท DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control
ROCHE DIAGNOSTICS TINA-QUANT IGM 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 K040431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2019 | Roche Diagnostics Corporation Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190
Product Usage:
Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and pl Terminated |
DAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.