K023763 is an FDA 510(k) clearance for the RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on January 13, 2003, 66 days after receiving the submission on November 8, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K023763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2002 |
| Decision Date | January 13, 2003 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |