The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Quikread(r) Whole Blood Triglyceride Test Kit.
Device ID | K897169 |
510k Number | K897169 |
Device Name: | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
Contact | Barry Mcdonald |
Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah, NJ 07430 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-28 |
Decision Date | 1990-02-23 |