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FDA 510(k) Application Details - K993706
Device Classification Name
Column Chromatography & Color Development, Hydroxyproline
More FDA Info for this Device
510(K) Number
K993706
Device Name
Column Chromatography & Color Development, Hydroxyproline
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS, IN 46250-0457 US
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Contact
PRISCILLA A HAMILL
Other 510(k) Applications for this Contact
Regulation Number
862.1400
More FDA Info for this Regulation Number
Classification Product Code
JMM
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More FDA Info for this Product Code
Date Received
11/02/1999
Decision Date
07/24/2000
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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