510(k) K953212 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Jul 31, 1995 |
| Received | Jul 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Randox Laboratories CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum
Catalogue number: CP3826 Open, Classified |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.