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FDA 510(k) Application Details - K040290
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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510(K) Number
K040290
Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant
DIASORIN S.P.A.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER, MN 55082-0285 US
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Contact
DAVID M IKEDA
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Regulation Number
866.3175
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Classification Product Code
LFZ
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More FDA Info for this Product Code
Date Received
02/06/2004
Decision Date
06/01/2005
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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