The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls.
| Device ID | K023763 |
| 510k Number | K023763 |
| Device Name: | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | Lynne Hamilton |
| Correspondent | Lynne Hamilton RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-08 |
| Decision Date | 2003-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273203134 | K023763 | 000 |
| 05055273203127 | K023763 | 000 |
| 05055273203110 | K023763 | 000 |