FDA 510(k) Application Details - K771849

Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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510(K) Number K771849
Device Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant MALLINCKRODT CRITICAL CARE

, US
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Regulation Number 862.1215

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Classification Product Code CGS
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Date Received 09/28/1977
Decision Date 11/03/1977
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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