CARESIDE GLUCOSE

Glucose Oxidase, Glucose

EXIGENT DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Exigent Diagnostics, Inc. with the FDA for Careside Glucose.

Pre-market Notification Details

Device IDK981183
510k NumberK981183
Device Name:CARESIDE GLUCOSE
ClassificationGlucose Oxidase, Glucose
Applicant EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-01
Decision Date1998-05-07
Summary:summary

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