FDA 510(k) Application Details - K772337

Device Classification Name Chromatography Separation/Zimmerman 17-Ketogenic Steroids

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510(K) Number K772337
Device Name Chromatography Separation/Zimmerman 17-Ketogenic Steroids
Applicant EPPENDORF-BRINKMANN, INC.

, US
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Regulation Number 862.1385

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Classification Product Code CDG
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Date Received 12/22/1977
Decision Date 01/12/1978
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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