FDA 510(k) Application Details - K801296

Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol

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510(K) Number K801296
Device Name Enzymatic Esterase--Oxidase, Cholesterol
Applicant ROCHE ANALYTICAL INSTRUMENTS, INC.

, US
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Regulation Number 862.1175

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Classification Product Code CHH
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Date Received 06/02/1980
Decision Date 06/30/1980
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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