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FDA 510(k) Application Details - K223403
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
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510(K) Number
K223403
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
DiaSorin Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater, MN 55082 US
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Contact
Kerrie Oetter
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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
11/09/2022
Decision Date
12/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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