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510(k) K944438

HEMAGEN CMV IGG KIT by Hemagen Diagnostics, Inc. — Product Code LFZ

K944438 is an FDA 510(k) premarket notification submitted by Hemagen Diagnostics, Inc. for the device "HEMAGEN CMV IGG KIT". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Hemagen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
September 12, 1994
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 Hemagen Diagnostics, Inc.

  • K041052 — RAICHEM GLUCOSE UV (LIQUID) (June 30, 2004)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (June 16, 2003)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (September 17, 2002)
  • K022767 — RAICHEM LIPID CALIBRATOR (September 3, 2002)
  • K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (July 29, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012668 — RAICHEM GLUCOSE UV REAGENT (October 15, 2001)

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)

FDA data resources