FDA 510(k) Application Details - K033899

Device Classification Name Test, Cholesterol, Total, Over The Counter

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510(K) Number K033899
Device Name Test, Cholesterol, Total, Over The Counter
Applicant LIFESTREAM TECHNOLOGIES, INC.
510 CLEARWATER LOOP, SUITE 101
POST FALLS, ID 83854 US
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Contact JACKSON CONNOLLY
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Regulation Number 862.1175

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Classification Product Code NFX
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Date Received 12/17/2003
Decision Date 05/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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