FDA 510(k) Application Details - K931970

Device Classification Name Analyzer, Enzyme, For Clinical Use

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510(K) Number K931970
Device Name Analyzer, Enzyme, For Clinical Use
Applicant ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK, IL US
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Contact MARY SPIEWAK
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Regulation Number 862.2500

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Classification Product Code JJI
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Date Received 04/22/1993
Decision Date 06/16/1993
Decision SE - Substantially Equivalent
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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