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FDA 510(k) Application Details - K092355
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
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510(K) Number
K092355
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND, WA 98052 US
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Contact
LINDA STASWICK
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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
08/04/2009
Decision Date
10/29/2009
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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