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FDA 510(k) Application Details - K061803
Device Classification Name
Control, Plasma, Abnormal
More FDA Info for this Device
510(K) Number
K061803
Device Name
Control, Plasma, Abnormal
Applicant
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY, NJ 07054 US
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Contact
LAURA WORFOLK
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
GGC
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More FDA Info for this Product Code
Date Received
06/27/2006
Decision Date
07/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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