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FDA 510(k) Application Details - K991063
Device Classification Name
Reagent, Borrelia Serological Reagent
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510(K) Number
K991063
Device Name
Reagent, Borrelia Serological Reagent
Applicant
IMMUNETICS, INC.
63 ROGERS ST.
CAMBRIDGE,, MA 02142 US
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Contact
ANDREW E LEVIN
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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
03/31/1999
Decision Date
09/21/1999
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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