The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Hdl-cholestral(dextran Sulfate/magnesium).
| Device ID | K932766 |
| 510k Number | K932766 |
| Device Name: | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Karen M Callbeck |
| Correspondent | Karen M Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1993-12-10 |