The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Quikread Whole Blood Hdl-cholesterol Test Kit.
Device ID | K894057 |
510k Number | K894057 |
Device Name: | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT |
Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
Applicant | PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
Contact | Mc Donald |
Correspondent | Mc Donald PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
Product Code | LBS |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-07 |
Decision Date | 1989-08-31 |