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Hcg Ria Pregnancy Test

by Hoffmann-La Roche, Inc.

510(k) K791206

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 NumberK791206 Date30 Jul 1979ClearedStatusActive

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  • Withdrawn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, 1 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 Hcg Ria Pregnancy Test is a device used for pregnancy testing. It is a type of radioimmunoassay (RIA) test that detects the presence of human chorionic gonadotropin (HCG) in a sample. The device is classified as a Clinical Chemistry device with a product code of JHI.

The Hcg Ria Pregnancy Test is supplied as a prescription use device and is regulated under 21 CFR 862.1155. It has been cleared through the Traditional 510(k) pathway with FDA clearance number K791206. The device is intended for use in a clinical setting and is subject to the regulations and guidelines set forth by the FDA.

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Questions

AI-generated answers, 1 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 HCG RIA Pregnancy Test used for?

    The HCG RIA Pregnancy Test is used to detect the presence of human chorionic gonadotropin (HCG) in a sample, indicating pregnancy.

  • How is the HCG RIA Pregnancy Test supplied?

    The HCG RIA Pregnancy Test is supplied as a prescription use device, intended for use in a clinical setting.

  • What is the regulatory classification of the HCG RIA Pregnancy Test?

    The HCG RIA Pregnancy Test is classified as a Clinical Chemistry device with a product code of JHI, regulated under 21 CFR 862.1155.

  • Is the HCG RIA Pregnancy Test cleared by the FDA?

    Yes, the HCG RIA Pregnancy Test has been cleared through the Traditional 510(k) pathway with FDA clearance number K791206.