BETA SCAN DRYSTIX

Glucose Oxidase, Glucose

ORANGE MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Beta Scan Drystix.

Pre-market Notification Details

Device IDK841369
510k NumberK841369
Device Name:BETA SCAN DRYSTIX
ClassificationGlucose Oxidase, Glucose
Applicant ORANGE MEDICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-03
Decision Date1984-08-23

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