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FDA 510(k) Application Details - K063329
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
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510(K) Number
K063329
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-6095 US
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Contact
JOSEPH C ORLOWSKI
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Regulation Number
866.3310
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Classification Product Code
LOL
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More FDA Info for this Product Code
Date Received
11/03/2006
Decision Date
04/16/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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