510(k) K001009 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
RANDOX C-REACTIVE PROTEIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | Mar 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2004 | Polymedco, Inc POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only.
COMMON/USUAL NAME: High-Sensitive C-Reactiv Terminated |
DCK | None listed |
| Jan 6, 2004 | Polymedco, Inc POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.