510(k) K061056 ยท JIX Calibrator, Multi-Analyte Mixture
RANDOX LIQUID PROTEIN CALIBRATOR
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jul 20, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2024 | Randox Laboratories Ltd. Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. Open, Classified |
JIX | None listed |
| Aug 23, 2023 | Randox Laboratories Ltd. Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferri Open, Classified |
JIX | None listed |
| Aug 9, 2019 | Randox Laboratories Ltd. Liquid Protein Calibrators (SP CAL (LIQ))
Catalogue Number: IT2691
GTIN: 05055273204032
Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Co Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.