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510(k) K162969

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set by DiaSorin, Inc. — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2017
Date Received
October 24, 2016
Clearance Type
Special
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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  • K163569 — Elecsys CMV IgM (March 17, 2017)
  • K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (October 24, 2014)
  • K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (February 28, 2014)
  • 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)