510(k) K042485 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Sep 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2017 | Roche Diagnostics Operations, Inc. Tina-Quant (Latex) HS Test System
(C-Reactive Protein (Latex) High Sensitive)
The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-re Terminated |
NQD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.