The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Hdl Precipitating Reagent (dextran Sulfate).
Device ID | K931773 |
510k Number | K931773 |
Device Name: | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) |
Classification | Ldl & Vldl Precipitation, Hdl |
Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Contact | Frances Loh |
Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Product Code | LBR |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-09 |
Decision Date | 1993-08-16 |