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FDA 510(k) Application Details - K032287
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K032287
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA, CA 92822-8000 US
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Contact
KIM WALKER
Other 510(k) Applications for this Contact
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
07/24/2003
Decision Date
08/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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