FDA 510(k) Application Details - K111932

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

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510(K) Number K111932
Device Name System, Test, Blood Glucose, Over The Counter
Applicant POSITIVEID CORPORATION
1690 S. CONGRESS AVENUE
Suite 200
Delray Beach, FL 33445 US
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Contact EDWARD VALDEZ
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 07/08/2011
Decision Date 11/10/2011
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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