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FDA 510(k) Application Details - K071277
Device Classification Name
Alkaline Picrate, Colorimetry, Creatinine
More FDA Info for this Device
510(K) Number
K071277
Device Name
Alkaline Picrate, Colorimetry, Creatinine
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.
M/S W-110
BREA, CA 92822-8000 US
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Contact
TARA M VIVIANI
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
CGX
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More FDA Info for this Product Code
Date Received
05/07/2007
Decision Date
06/01/2007
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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