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510(k) K921011

PHARMACIA CMV IGM ELISA by Pharmacia Diagnostics, Inc. — Product Code LFZ

K921011 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "PHARMACIA CMV IGM ELISA". The FDA issued a decision of Substantially Equivalent on July 27, 1992. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
March 3, 1992
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 Pharmacia Diagnostics, Inc.

  • K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, (February 7, 2006)
  • K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE (June 9, 2005)
  • K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (July 8, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)
  • K914022 — SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (January 27, 1992)
  • K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT (June 25, 1991)
  • K902793 — RUBELLA IGG (July 31, 1990)
  • K902792 — TOXOPLASMA GONDII IGG (July 24, 1990)

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