The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Direct Hdl-cholestrol Liquid.
| Device ID | K982341 |
| 510k Number | K982341 |
| Device Name: | DIRECT HDL-CHOLESTROL LIQUID |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| 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 | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201291 | K982341 | 000 |
| 00630414551784 | K982341 | 000 |
| 00630414508436 | K982341 | 000 |