Home / 510(k) Clearances / K963084

510(k) K963084

OPUS CMV TEST SYSTEM-MODIFICATION by Behring Diagnostics, Inc. — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1996
Date Received
August 8, 1996
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

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code LFZ

  • K220949 — Architect CMV IgG (October 27, 2022)
  • K220911 — Elecsys CMV IgG (October 12, 2022)
  • K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (July 30, 2018)
  • K163569 — Elecsys CMV IgM (March 17, 2017)
  • K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (January 6, 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)