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 |