Resubmitted Fecatwin Sensitive - Feca-Eia

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K896474 ↗

FDA Product Code

KHE

Device Class

Class II

Regulation

21 CFR Part 864.6550

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Rubella Igg Eia Test Kit

  Class II

  FDA 510(k) K853696 Active Cleared 17 Jun 1986

• 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

• Modified Labysystems' Toxoplasma Gondii Igg Eia

  Class II

  FDA 510(k) K890154 Active Cleared 7 Feb 1989

• 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. →