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FDA 510(k)

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY

K-Number: K854024 · 1985-11-26

ApplicantCorning Medical & Scientific
Decision Date1985-11-26
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1985-11-26 under 510(k) number K854024. 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 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY?

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Corning Medical & Scientific. The 510(k) number is K854024.

When did CORNING MAGIC MAB HCG RADIOIMMUNOASSAY receive FDA 510(k) clearance?

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY received FDA 510(k) clearance on 1985-11-26, under 510(k) number K854024.

Who is the listed applicant for CORNING MAGIC MAB HCG RADIOIMMUNOASSAY?

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

What is the FDA product code for CORNING MAGIC MAB HCG RADIOIMMUNOASSAY?

The FDA product code for CORNING MAGIC MAB HCG RADIOIMMUNOASSAY is JHI.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK853634CORNING CELL WELLS-MULTIPLE WELL PLATESK851939CORNING CERTAIN -ISE

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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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