Modified Labysystems' Toxoplasma Gondii Igg Eia

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K890154 ↗

FDA Product Code

LGD

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rubella Igg Eia Test Kit

  Class II

  FDA 510(k) K853696 Active Cleared 17 Jun 1986

• Resubmitted Fecatwin Sensitive - Feca-Eia

  Class II

  FDA 510(k) K896474 Active Cleared 25 Jan 1990

• Labsystems Fp-901 Chemistry Analyzer

  Class I

  FDA 510(k) K842773 Active Cleared 4 Sep 1984

• Rubella Igm Eia Test Kit

  Class II

  FDA 510(k) K862431 Active Cleared 8 Aug 1986

• Tilt/Reduced Shear Semi-recline Seating System

  Class II

  FDA 510(k) K923365 Active Cleared 24 Mar 1993

• Toxoplasma Gondii Igg Eia Test Kit (Amendment)

  Class II

  FDA 510(k) K862216 Active Cleared 30 Jun 1986

See all devices from Labsystems, Inc. →