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FDA 510(k) Application Details - K062319
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K062319
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD
P.O. BOX 50457
INDIANAPOLIS, IN 46250-0457 US
Other 510(k) Applications for this Company
Contact
CORINA HARPER
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/09/2006
Decision Date
09/13/2006
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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