QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

PHOTEC DIAGNOSTICS, INC.

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.

Pre-market Notification Details

Device IDK897169
510k NumberK897169
Device Name:QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
ContactBarry Mcdonald
CorrespondentBarry Mcdonald
PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-28
Decision Date1990-02-23

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