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FDA 510(k) Application Details - K080194
Device Classification Name
System, Test, Carcinoembryonic Antigen
More FDA Info for this Device
510(K) Number
K080194
Device Name
System, Test, Carcinoembryonic Antigen
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD, MO 63042 US
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Contact
NIKITA S MAPP
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Regulation Number
866.6010
More FDA Info for this Regulation Number
Classification Product Code
DHX
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More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
10/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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