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FDA 510(k) Application Details - K131546
Device Classification Name
Enzymatic, Carbon-Dioxide
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510(K) Number
K131546
Device Name
Enzymatic, Carbon-Dioxide
Applicant
BECKMAN COULTER IRELAND INC
250 S. KRAEMER BLVD. E1.SE.01
BREA, CA 92821 US
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Contact
DAVID G DAVIS
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Regulation Number
862.1160
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Classification Product Code
KHS
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More FDA Info for this Product Code
Date Received
05/29/2013
Decision Date
10/09/2013
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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