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510(k) K896295

CAPTIA(R) CMV-M by Mercia Diagnostics , Ltd. — Product Code LFZ

K896295 is an FDA 510(k) premarket notification submitted by Mercia Diagnostics , Ltd. for the device "CAPTIA(R) CMV-M". The FDA issued a decision of Substantially Equivalent on March 6, 1990. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Mercia Diagnostics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1990
Date Received
October 31, 1989
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 Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION (December 26, 1990)
  • K900654 — MODIFIED CAPTIA(R) SYPHILIS-M (March 8, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)
  • K880918 — CAPTIA TOXO-G (August 1, 1988)

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