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FDA 510(k) Application Details - K970643
Device Classification Name
Radioimmunoassay, Estradiol
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510(K) Number
K970643
Device Name
Radioimmunoassay, Estradiol
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
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Contact
ANN M QUINN
Other 510(k) Applications for this Contact
Regulation Number
862.1260
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Classification Product Code
CHP
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More FDA Info for this Product Code
Date Received
02/20/1997
Decision Date
03/18/1997
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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