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FDA 510(k)

HCG BETA RIA KIT

K-Number: K822152 · 1982-09-02

ApplicantClinetics Corp.
Decision Date1982-09-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG BETA RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinetics Corp.. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K822152. 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 BETA RIA KIT?

HCG BETA RIA KIT is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Clinetics Corp.. The 510(k) number is K822152.

When did HCG BETA RIA KIT receive FDA 510(k) clearance?

HCG BETA RIA KIT received FDA 510(k) clearance on 1982-09-02, under 510(k) number K822152.

Who is the listed applicant for HCG BETA RIA KIT?

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

What is the FDA product code for HCG BETA RIA KIT?

The FDA product code for HCG BETA RIA KIT is JHI.

Other records listing Clinetics Corp. 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.

K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KITK844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHK841580TSH RECEPTOR ANTIBODY KIT 125I TSHK833934ADRENOCORTICOTROPIC HORMONE TESTK830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.EK823380125-I LH RADIOIMMUNOASSAY KIT

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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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