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510(k) K981163

DIAMEDIX IS-CMV IGG TEST SYSTEM by Diamedix Corp. — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1998
Date Received
March 31, 1998
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 Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (July 9, 2002)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (December 21, 2001)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)

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)