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FDA 510(k) Application Details - K030621
Device Classification Name
Calibrator, Multi-Analyte Mixture
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510(K) Number
K030621
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA, CA 92821 US
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Contact
WYNN STOCKING
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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
02/27/2003
Decision Date
03/19/2003
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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