QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

PHOTEC DIAGNOSTICS, INC.

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.

Pre-market Notification Details

Device IDK894057
510k NumberK894057
Device Name:QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
ContactMc Donald
CorrespondentMc Donald
PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-07
Decision Date1989-08-31

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