FDA 510(k) Application Details - K003257

Device Classification Name Glucose Oxidase, Glucose

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510(K) Number K003257
Device Name Glucose Oxidase, Glucose
Applicant CYBERCARE TECHNOLOGIES, INC.
7840 ROSWELL RD., BLDG. 300
SUITE 320
ATLANTA, GA 30350-4889 US
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Contact GORDON J PETERS
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Regulation Number 862.1345

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Classification Product Code CGA
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Date Received 10/18/2000
Decision Date 12/22/2000
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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