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FDA 510(k) Application Details - K992124
Device Classification Name
Antigens, Nontreponemal, All
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510(K) Number
K992124
Device Name
Antigens, Nontreponemal, All
Applicant
AVANTI POLAR LIPIDS, INC.
700 INDUSTRIAL PARK DR.
ALABASTER, AL 35007-9105 US
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Contact
ROWENA SHAW
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Regulation Number
866.3820
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Classification Product Code
GMQ
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More FDA Info for this Product Code
Date Received
06/23/1999
Decision Date
09/20/1999
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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