FDA 510(k) Application Details - K760975

Device Classification Name Oncometer, Plasma, For Clinical Use

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510(K) Number K760975
Device Name Oncometer, Plasma, For Clinical Use
Applicant INSTRUMENTATION LABORATORY CO.

, US
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Regulation Number 862.2720

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Classification Product Code JJK
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Date Received 11/03/1976
Decision Date 01/12/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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