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FDA 510(k) Application Details - K120572
Device Classification Name
Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.
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510(K) Number
K120572
Device Name
Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.
Applicant
BIO-RAD LABORATORIES, INC.
5500 EAST 2ND ST.
BENICIA, CA 94510 US
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Contact
Juang Wang
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Regulation Number
866.3510
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Classification Product Code
OMI
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More FDA Info for this Product Code
Date Received
02/27/2012
Decision Date
03/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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