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FDA 510(k) Application Details - K132249
Device Classification Name
Radioimmunoassay, Free Thyroxine
More FDA Info for this Device
510(K) Number
K132249
Device Name
Radioimmunoassay, Free Thyroxine
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
MATTEW GEE
Other 510(k) Applications for this Contact
Regulation Number
862.1695
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Classification Product Code
CEC
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More FDA Info for this Product Code
Date Received
07/19/2013
Decision Date
09/13/2013
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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