The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Hdl-cholesterol Precipitating Reagent, Catalogue Number 205-51.
| Device ID | K980772 |
| 510k Number | K980772 |
| Device Name: | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-20 |
| Decision Date | 1998-04-27 |