510(k) K023763 ยท LCP Assay, Glycosylated Hemoglobin
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Jan 13, 2003 |
| Received | Nov 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Calibrator, FR2993
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JIT | None listed |
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Control 1, FR2994
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JJX | None listed |
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Control 3, FR2996
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.