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FDA 510(k) Application Details - K090283
Device Classification Name
Calibrator, Multi-Analyte Mixture
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510(K) Number
K090283
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
GENCHEM, INC.
510 WEST CENTRAL AVE., SUITE D
BREA, CA 92821 US
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Contact
JAMES M HENNEMAN
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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
02/05/2009
Decision Date
06/05/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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