BIOSCANNER CREATININE TEST STRIPS

Enzymatic Method, Creatinine

POLYMER TECHNOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Bioscanner Creatinine Test Strips.

Pre-market Notification Details

Device IDK010456
510k NumberK010456
Device Name:BIOSCANNER CREATININE TEST STRIPS
ClassificationEnzymatic Method, Creatinine
Applicant POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis,  IN  46268
ContactMargo Enright
CorrespondentMargo Enright
POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis,  IN  46268
Product CodeJFY  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-16
Decision Date2001-06-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00381931720015 K010456 000

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