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FDA 510(k) Application Details - K011658
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K011658
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
ROCHDIAG
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
HELEN T TORNEY
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Regulation Number
862.1150
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Classification Product Code
JIX
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More FDA Info for this Product Code
Date Received
05/29/2001
Decision Date
07/31/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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