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510(k) K142133

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM by Roche Diagnostics — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2014
Date Received
August 4, 2014
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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Other clearances for product code LFZ

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  • K040290 — DIASORIN LIAISON CMV IGM/IGG (June 1, 2005)
  • K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (December 16, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)
  • K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LI (January 11, 1999)