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FDA 510(k) Application Details - K160590
Device Classification Name
Mixture, Hematology Quality Control
More FDA Info for this Device
510(K) Number
K160590
Device Name
Mixture, Hematology Quality Control
Applicant
STRECK
7002 S. 109TH STREET
LA VISTA, NE 68128 US
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Contact
DEBORAH KIPP
Other 510(k) Applications for this Contact
Regulation Number
864.8625
More FDA Info for this Regulation Number
Classification Product Code
JPK
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More FDA Info for this Product Code
Date Received
03/01/2016
Decision Date
12/22/2016
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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