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Hem Ave-Toxo Titration Hemagglutination Test Kit

by Si Sero-Immuno Diagnostics, Inc. 510(k)

Active United States

510(k) K851977

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851977 Date16 Oct 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GMM
Device Class
Class II
Regulation
21 CFR Part 866.3780
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT is an antigen-based in vitro diagnostic device used for the detection of antibodies to Toxoplasma gondii via hemagglutination assay. It is classified as a Class II medical device under regulation number 866.3780 and falls within the microbiology specialty.

The device received FDA 510(k) clearance (K851977) on October 16, 1985, as substantially equivalent to a predicate device. It is manufactured by Si Sero-Immuno Diagnostics, Inc., located in Tucker, Georgia, and is intended for use in laboratory settings for serological testing.

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