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FDA 510(k) Application Details - K081683
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K081683
Device Name
Calibrator, Secondary
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK, DE 19714-6101 US
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Contact
YUK-TING LEWIS
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
06/17/2008
Decision Date
07/07/2008
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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