FDA 510(k) Application Details - K974260

Device Classification Name Column Chromatography & Color Development, Hydroxyproline

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510(K) Number K974260
Device Name Column Chromatography & Color Development, Hydroxyproline
Applicant METRA BIOSYSTEMS, INC.
265 NORTH WHISMAN RD.
MOUNTAIN VIEW, CA 94043-3911 US
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Contact DAVID CASAL
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Regulation Number 862.1400

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Classification Product Code JMM
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Date Received 11/13/1997
Decision Date 01/26/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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