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FDA 510(k) Application Details - K083462
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K083462
Device Name
Calibrator, Secondary
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE M/S 514
NEWARK, DE 19714 US
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Contact
HELEN M LEE
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2008
Decision Date
02/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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