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FDA 510(k) Application Details - K103529
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
More FDA Info for this Device
510(K) Number
K103529
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
DIASORIN, INC.
195 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER, MN 55082 US
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Contact
Mari Meyer
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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
12/01/2010
Decision Date
01/21/2011
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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