GLUCOCHEK POCKETLAB

Glucose Oxidase, Glucose

CLINICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Glucochek Pocketlab.

Pre-market Notification Details

Device IDK951457
510k NumberK951457
Device Name:GLUCOCHEK POCKETLAB
ClassificationGlucose Oxidase, Glucose
Applicant CLINICAL DIAGNOSTICS, INC. 132 MAIN STREET, SUITE A Chester,  SC  29706
ContactCharles F Neilson
CorrespondentCharles F Neilson
CLINICAL DIAGNOSTICS, INC. 132 MAIN STREET, SUITE A Chester,  SC  29706
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-29
Decision Date1996-02-22

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