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FDA 510(k) Application Details - K140829
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K140829
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BLVD.
MAIL STOP E1.SE.01
BREA, CA 92821 US
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Contact
ANNETTE HELLIE
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
04/01/2014
Decision Date
07/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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