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510(k) K131605

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY by Roche Diagnostics — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2014
Date Received
June 3, 2013
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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