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 |