QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA

Enzymatic Esterase--oxidase, Cholesterol

PHOTEC DIAGNOSTICS, INC.

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.

Pre-market Notification Details

Device IDK890267
510k NumberK890267
Device Name:QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
ContactBarry Mcdonald
CorrespondentBarry Mcdonald
PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-04
Decision Date1989-04-26

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