FDA 510(k) Application Details - K022724

Device Classification Name System, Test, Blood Glucose, Over The Counter

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510(K) Number K022724
Device Name System, Test, Blood Glucose, Over The Counter
Applicant LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS, CA 95035-6312 US
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Contact JOHN E HUGHES
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 08/16/2002
Decision Date 09/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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