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LAS-R Human C3 Proactivator Test

by Hyland Therapeutic Div., Travenol Laboratories

510(k) K772084

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772084 Date24 Jan 1978ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JZH
Device Class
Class II
Regulation
21 CFR Part 866.5320
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 LAS-R Human C3 Proactivator Test is a Factor B, Antigen, Antiserum, Control device used in immunology. It is designed for laboratory testing related to complement system activation.

This device received FDA 510(k) clearance under K772084 and is classified as a Class II medical device. It is supplied non-sterile and intended for use in clinical laboratory settings by trained professionals.

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