GLUCOSE TEST ITEM NUMBER 97375/94

Glucose Dehydrogenase, Glucose

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Glucose Test Item Number 97375/94.

Pre-market Notification Details

Device IDK951750
510k NumberK951750
Device Name:GLUCOSE TEST ITEM NUMBER 97375/94
ClassificationGlucose Dehydrogenase, Glucose
Applicant EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown,  NJ  08027
ContactCarol Faulkner
CorrespondentCarol Faulkner
EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown,  NJ  08027
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-17
Decision Date1995-09-06

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