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FDA 510(k) Application Details - K072721
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K072721
Device Name
Drug Mixture Control Materials
Applicant
BIO-RAD, DIAGNOSTICS GRP.
9500 JERONIMO RD.
IRVINE, CA 92618-2017 US
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Contact
ELIZABETH PLATT
Other 510(k) Applications for this Contact
Regulation Number
862.3280
More FDA Info for this Regulation Number
Classification Product Code
DIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2007
Decision Date
12/11/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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