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Coated Tube IRMA TSH

by Bio Mega Diagnostic, Inc.

510(k) K864659

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 NumberK864659 Date4 Feb 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Bio-Mega Diagnostic Coated Tube Irma Tsh
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, 19 Sep 2026

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

This device is a Radioimmunoassay (RIA) Coated Tube designed for the quantitative measurement of human thyroid-stimulating hormone (TSH) in serum or plasma. It employs an immunoradiometric assay (IRMA) with coated tubes, where monoclonal antibodies are immobilized on the tube’s inner surface to facilitate separation and detection of TSH levels.

The Coated Tube IRMA TSH is intended for in vitro diagnostic use in clinical chemistry settings. Supplied as a single-use kit, it requires no special storage conditions beyond those specified in the accompanying instructions. The device holds FDA 510(k) clearance (K864659) under the regulatory classification 21 CFR 862.1690, with no third-party involvement. Compliance with sterility and performance standards is ensured through the manufacturer’s validation processes.

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