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FDA 510(k) Application Details - K972394
Device Classification Name
Antigens (Febrile), Agglutination, Brucella Spp.
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510(K) Number
K972394
Device Name
Antigens (Febrile), Agglutination, Brucella Spp.
Applicant
LEE LABORATORIES, INC.
1475 HWY. 78, S.W.
GRAYSON, GA 30221 US
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Contact
ROBIN C HART
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Regulation Number
866.3085
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Classification Product Code
GSO
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More FDA Info for this Product Code
Date Received
06/26/1997
Decision Date
08/25/1997
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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