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FDA 510(k) Application Details - K964960
Device Classification Name
Lowry (Colorimetric), Total Protein
More FDA Info for this Device
510(K) Number
K964960
Device Name
Lowry (Colorimetric), Total Protein
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
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Contact
CHARLES C MORGANSON, JR.
Other 510(k) Applications for this Contact
Regulation Number
862.1635
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Classification Product Code
JGP
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More FDA Info for this Product Code
Date Received
12/11/1996
Decision Date
02/18/1997
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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