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FDA 510(k) Application Details - K091742
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K091742
Device Name
Enzymatic Method, Creatinine
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.
M/S W-110
BREA, CA 92822-8000 US
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Contact
MARINE BOYAJIAN
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
06/16/2009
Decision Date
08/14/2009
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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