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FDA 510(k) Application Details - K081543
Device Classification Name
Radioimmunoassay, Thyroid-Stimulating Hormone
More FDA Info for this Device
510(K) Number
K081543
Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DRIVE
MC881
ROCHESTER, NY 14626-5101 US
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Contact
LEAH VAN DE WATER
Other 510(k) Applications for this Contact
Regulation Number
862.1690
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Classification Product Code
JLW
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More FDA Info for this Product Code
Date Received
06/02/2008
Decision Date
10/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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