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FDA 510(k) Application Details - K010696
Device Classification Name
Calibrator, Primary
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510(K) Number
K010696
Device Name
Calibrator, Primary
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
RICHARD T ROSS
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Regulation Number
862.1150
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Classification Product Code
JIS
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More FDA Info for this Product Code
Date Received
03/08/2001
Decision Date
05/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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