FDA 510(k) Application Details - K823579

Device Classification Name Biuret (Colorimetric), Total Protein

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510(K) Number K823579
Device Name Biuret (Colorimetric), Total Protein
Applicant HOFFMANN-LA ROCHE, INC.

, US
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Regulation Number 862.1635

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Classification Product Code CEK
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Date Received 12/06/1982
Decision Date 01/07/1983
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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