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FDA 510(k) Application Details - K980283
Device Classification Name
Enzyme Immunoassay, Carbamazepine
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510(K) Number
K980283
Device Name
Enzyme Immunoassay, Carbamazepine
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
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Contact
CHARLES C MORGANSON
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Regulation Number
862.3645
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Classification Product Code
KLT
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More FDA Info for this Product Code
Date Received
01/26/1998
Decision Date
02/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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