The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Boehringer Mannheim Direct Hdl-cholesterol.
| Device ID | K970735 |
| 510k Number | K970735 |
| Device Name: | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P. Armstong |
| Correspondent | P. Armstong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE 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 | 1997-02-18 |
| Decision Date | 1997-06-06 |