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Thyrodot-4, Thyrodot-Sh

by Medcom Diagnostics, Inc.

510(k) K771377

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 NumberK771377 Date2 Sep 1977ClearedStatusActive

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  • Withdrawn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, 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 for thyroid-stimulating hormone (TSH) used in clinical chemistry. It is designed to measure TSH levels in patient samples.

The device is supplied as THYRODOT-4 and THYRODOT-SH variants, with FDA 510(k) clearance K771377 granted on September 2, 1977. It is classified as a Class II medical device under regulation number 862.1690 and product code JLW.

Other devices from Medcom Diagnostics, Inc.

Questions

AI-generated answers, 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.

  • What is the THYRODOT-4 and THYRODOT-SH device used for?

    The THYRODOT-4 and THYRODOT-SH devices are radioimmunoassays designed to measure thyroid-stimulating hormone (TSH) levels in patient samples within clinical chemistry settings, as specified in the device description.

  • How is the THYRODOT-4 and THYRODOT-SH device supplied?

    The device is supplied as two variants: THYRODOT-4 and THYRODOT-SH, which are distinct product models offered by Medcom Diagnostics, Inc. for use in TSH testing.

  • What regulatory pathway was used for the THYRODOT-4 and THYRODOT-SH device?

    The device received FDA 510(k) clearance under submission K771377, which was granted on September 2, 1977, following a traditional review process and a determination of substantial equivalence.

  • Is the THYRODOT-4 and THYRODOT-SH device sterile or single-use?

    The provided device data does not specify whether the THYRODOT-4 or THYRODOT-SH variants are sterile, single-use, or reusable; therefore, no conclusion can be drawn about sterility or reusability from the available information.

  • What classification and product code apply to the THYRODOT-4 and THYRODOT-SH device?

    The device is classified as a Class II medical device under regulation number 862.1690 and is assigned product code JLW, as indicated in the device data.