The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Quikread Chem. Analyzer & Choles. For Serum/plasma.
Device ID | K890267 |
510k Number | K890267 |
Device Name: | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Contact | Barry Mcdonald |
Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-04 |
Decision Date | 1989-04-26 |