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FDA 510(k) Application Details - K063318
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
More FDA Info for this Device
510(K) Number
K063318
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
Bio-Rad Laboratories
3 BD RAYMOND POINCARE
MARNES-LA-COQUETTE
HAUTS-DE-SEINE 92430 FR
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Contact
MANUELA KAUL
Other 510(k) Applications for this Contact
Regulation Number
866.3310
More FDA Info for this Regulation Number
Classification Product Code
LOL
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More FDA Info for this Product Code
Date Received
11/02/2006
Decision Date
05/03/2007
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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