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FDA 510(k) Application Details - K162969
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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510(K) Number
K162969
Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285 US
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Contact
John Walter
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Regulation Number
866.3175
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Classification Product Code
LFZ
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Date Received
10/24/2016
Decision Date
01/06/2017
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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