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FDA 510(k)

HCG RIA TEST SYSTEM

K-Number: K854958 · 1986-01-28

ApplicantMonobind
Decision Date1986-01-28
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG RIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1986-01-28 under 510(k) number K854958. 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 HCG RIA TEST SYSTEM?

HCG RIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-28. The listed applicant is Monobind. The 510(k) number is K854958.

When did HCG RIA TEST SYSTEM receive FDA 510(k) clearance?

HCG RIA TEST SYSTEM received FDA 510(k) clearance on 1986-01-28, under 510(k) number K854958.

Who is the listed applicant for HCG RIA TEST SYSTEM?

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

What is the FDA product code for HCG RIA TEST SYSTEM?

The FDA product code for HCG RIA TEST SYSTEM is JHI.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

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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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