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FDA 510(k) Application Details - K964721
Device Classification Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
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510(K) Number
K964721
Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
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ANN M QUINN
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Regulation Number
862.1700
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Classification Product Code
KLI
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More FDA Info for this Product Code
Date Received
11/25/1996
Decision Date
12/18/1996
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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