The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Lipid Control.
| Device ID | K022591 |
| 510k Number | K022591 |
| Device Name: | RANDOX LIPID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439020031 | K022591 | 000 |
| 00817439020024 | K022591 | 000 |
| 00817439020000 | K022591 | 000 |