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FDA 510(k) Application Details - K111762
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K111762
Device Name
Calibrator, Secondary
Applicant
Tosoh BioScience, Inc.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
JUDITH K OGDEN
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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
06/23/2011
Decision Date
08/05/2011
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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