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FDA 510(k) Application Details - K964720
Device Classification Name
Radioimmunoassay, Follicle-Stimulating Hormone
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510(K) Number
K964720
Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
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
862.1300
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Classification Product Code
CGJ
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More FDA Info for this Product Code
Date Received
11/25/1996
Decision Date
02/04/1997
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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