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FDA 510(k) Application Details - K070820
Device Classification Name
Enzyme Immunoassay, Tracrolimus
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510(K) Number
K070820
Device Name
Enzyme Immunoassay, Tracrolimus
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN, PA 19355-1307 US
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Contact
DIANA DICKSON
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Regulation Number
862.1678
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Classification Product Code
MLM
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More FDA Info for this Product Code
Date Received
03/26/2007
Decision Date
08/01/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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