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FDA 510(k) Application Details - K031898
Device Classification Name
System, Hemoglobin, Automated
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510(K) Number
K031898
Device Name
System, Hemoglobin, Automated
Applicant
EKF DIAGNOSTIC GMBH
S65 W35739 PIPER ROAD
EAGLE, WI 53119 US
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Contact
STEPHEN GORSKI
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Regulation Number
864.5620
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Classification Product Code
GKR
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More FDA Info for this Product Code
Date Received
06/19/2003
Decision Date
09/24/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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