Synelisa Parietal Cell Antibodies

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K930422 ↗

FDA Product Code

DBJ

Device Class

Class II

Regulation

21 CFR Part 866.5110

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. →

• What is the primary purpose of the Synelisa Parietal Cell Antibodies test?

  This device is an immunological test system designed to measure the presence of specific antibodies for gastric parietal cells. It utilizes immunochemical techniques to analyze serum and other body fluids for clinical evaluation.

• How is this device classified for regulatory purposes?

  The Synelisa Parietal Cell Antibodies system is classified as a Class 2 immunology device under regulation number 866.5110. It received FDA 510(k) clearance through the traditional pathway under K930422.

• What technology does the Synelisa system use to detect antibodies?

  The system employs immunochemical techniques to identify and measure specific antibodies associated with gastric parietal cells. This methodology allows for the analysis of these antibodies within serum or other body fluid samples.