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FDA 510(k) Application Details - K953682
Device Classification Name
Reagent, Borrelia Serological Reagent
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510(K) Number
K953682
Device Name
Reagent, Borrelia Serological Reagent
Applicant
GenBio
15222 AVE. OF SCIENCE, SUITE A
SAN DIEGO, CA 92128 US
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Contact
Bryan Kiehl
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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
08/07/1995
Decision Date
05/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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