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Micro-ELISA TSH Test Kit-Visi-Check TSH Test Kit

by Bioclinical Systems, Inc.

510(k) K854379

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854379 Date7 Jan 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The device is a radioimmunoassay for thyroid-stimulating hormone (TSH) as defined in the device name and openFDA data. It is a test kit used for measuring TSH levels in clinical chemistry settings.

It is supplied as a test kit for in vitro diagnostic use, with FDA 510(k) clearance under K854379, classified as a Class II device. The product is intended for use in clinical laboratories and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT used for?

    This device is a radioimmunoassay designed to measure thyroid-stimulating hormone (TSH) levels in serum or plasma samples, intended for use in clinical laboratories to assess thyroid function as part of diagnostic evaluation for thyroid disorders.

  • How is the MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT supplied and what is its intended use?

    The test kit is supplied as an in vitro diagnostic (IVD) test kit for use in clinical chemistry laboratories, containing all necessary reagents and materials to perform TSH radioimmunoassay testing on patient specimens outside the body.

  • Is the MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT sterile, single-use, or reusable?

    The provided data does not specify whether the device is sterile, single-use, or reusable; it is described only as a test kit for in vitro diagnostic use with no indication of sterility or reuse characteristics in the labeling or specifications.