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FDA 510(k) Application Details - K110251
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K110251
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA, CA 92821 US
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Contact
Yvette Lloyd
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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
01/28/2011
Decision Date
05/25/2011
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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