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510(k) K875363

SERODOT TOXOPLASMA IGG TEST KIT by Disease Detection International, Inc. — Product Code LGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
December 31, 1987
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 Disease Detection International, Inc.

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  • K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (July 19, 1991)
  • K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST (September 5, 1990)
  • K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT (August 9, 1990)
  • K895912 — IMMUNOCARD HCG II-S TEST KIT (December 1, 1989)
  • K896109 — IMMUNOCARD STREP A TEST (November 29, 1989)
  • K884247 — MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (April 10, 1989)
  • K884248 — MODIFIED DDI SEROCARD CMV IGG TEST KIT (April 10, 1989)

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)