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FDA 510(k) Application Details - K030065
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K030065
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND, VA 23237 US
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Contact
TONYA MALLORY
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJX
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More FDA Info for this Product Code
Date Received
01/07/2003
Decision Date
02/11/2003
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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