Synelisa Tmab

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K915133 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Elias Ena Screen (Microtiter Plate)

  Class II

  FDA 510(k) K940622 Active Cleared 11 May 1994

• Varelisa Helicobacter Pylori Antibodies

  Class I

  FDA 510(k) K953873 Active Cleared 30 Aug 1996

• Varelisa Combined DNA Antibodies Eia

  Class II

  FDA 510(k) K944334 Active Cleared 17 Apr 1995

• Synelisa Tgab/Tmab

  Class II

  FDA 510(k) K915135 Active Cleared 8 Apr 1992

• Synelisa Cardiolipin Antibodies

  Class II

  FDA 510(k) K924421 Active Cleared 30 Nov 1992

• Syn Elisa Micro Albumin

  Class I

  FDA 510(k) K920216 Active Cleared 11 Mar 1992

See all devices from Elias U.S.A., Inc. →