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FDA 510(k) Application Details - K062024
Device Classification Name
Enzyme Immunoassay, Digitoxin
More FDA Info for this Device
510(K) Number
K062024
Device Name
Enzyme Immunoassay, Digitoxin
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK, DE 19714-6101 US
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Contact
LORRAINE H PIESTRAK
Other 510(k) Applications for this Contact
Regulation Number
862.3300
More FDA Info for this Regulation Number
Classification Product Code
LFM
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More FDA Info for this Product Code
Date Received
07/18/2006
Decision Date
07/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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