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FDA 510(k) Application Details - K992997
Device Classification Name
Column Chromatography & Color Development, Hydroxyproline
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510(K) Number
K992997
Device Name
Column Chromatography & Color Development, Hydroxyproline
Applicant
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE, CA 94085-4022 US
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Contact
Erika B Ammirati
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Regulation Number
862.1400
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Classification Product Code
JMM
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More FDA Info for this Product Code
Date Received
09/07/1999
Decision Date
11/09/1999
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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