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FDA 510(k) Application Details - K001607
Device Classification Name
Radioimmunoassay, Total Triiodothyronine
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510(K) Number
K001607
Device Name
Radioimmunoassay, Total Triiodothyronine
Applicant
REPROMEDIX CORP.
86 CUMMINGS PARK,
WOBURN, MA 01801 US
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Contact
HAN-SOO KIM
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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
05/24/2000
Decision Date
10/05/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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