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FDA 510(k) Application Details - K962235
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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510(K) Number
K962235
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
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BRADFORD M SPRING
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Regulation Number
862.2160
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Classification Product Code
JJE
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More FDA Info for this Product Code
Date Received
06/11/1996
Decision Date
06/26/1996
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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