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FDA 510(k) Application Details - K143144
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K143144
Device Name
Calibrator, Secondary
Applicant
Tosoh BioScience, Inc.
6000 Shoreline Court, Ste. 101
South San Francisco, CA 94080 US
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Contact
Robert L Wick
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
11/03/2014
Decision Date
12/03/2014
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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