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510(k) K040290

DIASORIN LIAISON CMV IGM/IGG by Diasorin S.P.A — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2005
Date Received
February 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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  • K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (October 24, 2014)
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  • K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (December 16, 1999)
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  • K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LI (January 11, 1999)