The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Lipoprotein.
| Device ID | K011568 |
| 510k Number | K011568 |
| Device Name: | RANDOX LIPOPROTEIN |
| Classification | Calibrator, Primary |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | JIS |
| Subsequent Product Code | DFC |
| Subsequent Product Code | JJS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2001-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439021076 | K011568 | 000 |
| 00817439021052 | K011568 | 000 |
| 05055273209198 | K011568 | 000 |
| 05055273204438 | K011568 | 000 |
| 05055273204421 | K011568 | 000 |
| 05055273204384 | K011568 | 000 |
| 05051700016841 | K011568 | 000 |