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FDA 510(k) Application Details - K080012
Device Classification Name
Reagent, Borrelia Serological Reagent
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510(K) Number
K080012
Device Name
Reagent, Borrelia Serological Reagent
Applicant
BIO-RAD
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
866.3830
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Classification Product Code
LSR
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More FDA Info for this Product Code
Date Received
01/03/2008
Decision Date
05/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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