The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Direct Ldl Cholesterol.
| Device ID | K982529 |
| 510k Number | K982529 |
| Device Name: | RANDOX DIRECT LDL CHOLESTEROL |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201307 | K982529 | 000 |
| 00630414596181 | K982529 | 000 |
| 00630414470542 | K982529 | 000 |