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FDA 510(k) Application Details - K052015
Device Classification Name
Calibrators, Drug Specific
More FDA Info for this Device
510(K) Number
K052015
Device Name
Calibrators, Drug Specific
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
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Contact
ANDREA M TASKER
Other 510(k) Applications for this Contact
Regulation Number
862.3200
More FDA Info for this Regulation Number
Classification Product Code
DLJ
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More FDA Info for this Product Code
Date Received
07/26/2005
Decision Date
09/12/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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