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Roche B-Hcg Ria

by Hoffmann-La Roche, Inc.

510(k) K820613

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 NumberK820613 Date1 Apr 1982ClearedStatusActive

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  • Withdrawn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
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
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 Roche B-Hcg Ria is a clinical chemistry device used for the measurement of human chorionic gonadotropin (HCG) in plasma. It is a Class 2 device with product code JHI. The device is intended for the early detection of pregnancy by measuring HCG, a placental hormone.

The Roche B-Hcg Ria is supplied as a prescription use device, cleared through the Traditional 510(k) pathway. It has been assigned the regulation number 862.1155 and has FDA 510(k) clearance, with the k number K820613. The device is manufactured by Hoffmann-La Roche, Inc.

Other devices from Hoffmann-La Roche, Inc.

See all devices from Hoffmann-La Roche, Inc. →

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 Roche B-HCG Ria used for?

    The Roche B-HCG Ria is used for the early detection of pregnancy by measuring human chorionic gonadotropin (HCG) in plasma.

  • Is the Roche B-HCG Ria a prescription use device?

    Yes, the Roche B-HCG Ria is supplied as a prescription use device.

  • What is the product code for the Roche B-HCG Ria?

    The product code for the Roche B-HCG Ria is JHI.

  • What is the regulation number for the Roche B-HCG Ria?

    The regulation number for the Roche B-HCG Ria is 862.1155.