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510(k) K920702

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO by Pharmacia Diagnostics, Inc. — Product Code LGD

K920702 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO". The FDA issued a decision of Substantially Equivalent on July 8, 1992. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
February 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
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)
  • K921011 — PHARMACIA CMV IGM ELISA (July 27, 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 LGD

  • K242022 — Access Toxo IgG (March 28, 2025)
  • K242095 — Access Toxo IgM II (October 11, 2024)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K210596 — ARCHITECT Toxo IgG (May 19, 2022)
  • K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (June 23, 2017)
  • K142826 — ADVIA Centaur Toxoplasma M (Toxo M) (December 22, 2015)
  • K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (August 28, 2013)
  • K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (August 9, 2013)
  • K101946 — VIDAS TOXO IGG AVIDITY (May 18, 2011)
  • K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (May 4, 2011)

FDA data resources