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FDA 510(k) Application Details - K183571
Device Classification Name
Antigen, Iha, Cytomegalovirus
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510(K) Number
K183571
Device Name
Antigen, Iha, Cytomegalovirus
Applicant
Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071 US
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Contact
Howard Yorek
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Regulation Number
866.3175
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Classification Product Code
LJO
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More FDA Info for this Product Code
Date Received
12/21/2018
Decision Date
02/04/2019
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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