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Access Htsh Assay

by Bio-Rad Laboratories, Inc. 510(k)

Active United States

510(k) K925637

Overview

The ACCESS HTSH ASSAY is a radioimmunoassay for thyroid-stimulating hormone (TSH) used in clinical chemistry test systems. It is a Class 2 medical device with product code JLW, cleared by the FDA through the traditional 510(k) pathway.

The device was cleared under K925637 on March 1, 1993, following a 112-day review. It is manufactured by Bio-Rad Laboratories, Inc. and is intended for use in clinical laboratory settings as part of in vitro diagnostic testing for TSH levels.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925637 Date1 Mar 1993ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ACCESS HTSH ASSAY used for?

    The ACCESS HTSH ASSAY is a radioimmunoassay designed to measure thyroid-stimulating hormone (TSH) levels in patient samples as part of in vitro diagnostic testing in clinical chemistry laboratories.

  • How is the ACCESS HTSH ASSAY supplied and intended for use?

    The device is supplied as a test system for use in clinical laboratory settings, intended for in vitro diagnostic measurement of TSH levels, and is not intended for point-of-care or home use.

  • Is the ACCESS HTSH ASSAY a single-use or reusable device?

    As a radioimmunoassay test system, the ACCESS HTSH ASSAY involves reagents and components that are consumed during testing and are intended for single-use per test cycle, consistent with standard clinical laboratory immunoassay procedures.