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FDA 510(k) Application Details - K955435
Device Classification Name
Radioimmunoassay, Total Triiodothyronine
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510(K) Number
K955435
Device Name
Radioimmunoassay, Total Triiodothyronine
Applicant
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
DENNIS GRIFFIN
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Regulation Number
862.1710
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Classification Product Code
CDP
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More FDA Info for this Product Code
Date Received
10/02/1995
Decision Date
01/24/1996
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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