SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.

Glucose Oxidase, Glucose

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Glucose (hk) Reagent Strips,module,cali..

Pre-market Notification Details

Device IDK864530
510k NumberK864530
Device Name:SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
ClassificationGlucose Oxidase, Glucose
Applicant MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
ContactJohn H Engelmann
CorrespondentJohn H Engelmann
MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-17
Decision Date1987-02-18

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