MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON

Glucose Oxidase, Glucose

POLYMER TECHNOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Mtm Bioscanner 1000 Test System Consisting Of Mtm Bioscanner 1000 Meter, Mtm Bioscanner G Test Strip, Norman Glucose Con.

Pre-market Notification Details

Device IDK972669
510k NumberK972669
Device Name:MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
ClassificationGlucose Oxidase, Glucose
Applicant POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis,  IN  46268
ContactJames M Connolly
CorrespondentJames M Connolly
POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis,  IN  46268
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-16
Decision Date1998-01-22

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