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FDA 510(k) Application Details - K980518
Device Classification Name
Column Chromatography & Color Development, Hydroxyproline
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510(K) Number
K980518
Device Name
Column Chromatography & Color Development, Hydroxyproline
Applicant
OSTEX INTL., INC.
2203 AIRPORT WAY SOUTH,
SUITE 400
SEATTLE, WA 98134 US
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Contact
NANCY JS MALLINAK
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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
01/16/1998
Decision Date
03/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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