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FDA 510(k) Application Details - K142302
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K142302
Device Name
Glucose Oxidase, Glucose
Applicant
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis, IN 46268 US
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Contact
Jack Rogers
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Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
08/18/2014
Decision Date
10/02/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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