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FDA 510(k)

RIAGEN B-HCG RIA KIT

K-Number: K831221 · 1983-06-02

ApplicantBiogenex Laboratories
Decision Date1983-06-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIAGEN B-HCG RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831221. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIAGEN B-HCG RIA KIT?

RIAGEN B-HCG RIA KIT is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Biogenex Laboratories. The 510(k) number is K831221.

When did RIAGEN B-HCG RIA KIT receive FDA 510(k) clearance?

RIAGEN B-HCG RIA KIT received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831221.

Who is the listed applicant for RIAGEN B-HCG RIA KIT?

The FDA 510(k) record lists Biogenex Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIAGEN B-HCG RIA KIT?

The FDA product code for RIAGEN B-HCG RIA KIT is JHI.

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Other records listing Biogenex Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K925189PREGNAGEN 1-STEP PREGNANCY TESTK902208MODIFIED OVUGENK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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