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FDA 510(k) Application Details - K163521
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K163521
Device Name
Calibrator, Secondary
Applicant
FUJIREBIO DIAGNOSTICS, INC
201 GREAT VALLEY PARKWAY
MALVERN, PA 19355 US
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Contact
DIANA DICKSON
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
12/15/2016
Decision Date
01/12/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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