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FDA 510(k) Application Details - K040352
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K040352
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BIORESOURCE TECHNOLOGY, INC.
1531 N.W. 65TH AVE.
FORT LAUDERDALE, FL 33313-4542 US
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Contact
ALAN POSNER
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
02/12/2004
Decision Date
04/02/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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