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FDA 510(k) Application Details - K120199
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K120199
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BECKMAN COULTER, INC
250 S. KRAEMER BLVD
MAIL STOP A2 SW. 08
BREA, CA 92821 US
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BEVERLY HARDING
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Regulation Number
864.7470
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Classification Product Code
LCP
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Date Received
01/23/2012
Decision Date
10/12/2012
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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