The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Haemoglobin A1c.
| Device ID | K021897 |
| 510k Number | K021897 |
| Device Name: | RANDOX HAEMOGLOBIN A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208856 | K021897 | 000 |
| 05055273203561 | K021897 | 000 |
| 05055273203530 | K021897 | 000 |