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510(k) K921523

OPUS(R) TOXO-G TEST SYSTEM by Pb Diagnostics, Inc. — Product Code LGD

K921523 is an FDA 510(k) premarket notification submitted by Pb Diagnostics, Inc. for the device "OPUS(R) TOXO-G TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 1992. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Pb Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1992
Date Received
March 31, 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 Pb Diagnostics, Inc.

  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)
  • K915870 — OPUS RUBELLA TEST SYSTEM (March 23, 1992)
  • K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)

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