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FDA 510(k)

SINGLE STEP FREE-T4 125I RADIOIMMUNO-

K-Number: K823144 · 1982-11-29

ApplicantCorning Medical & Scientific
Decision Date1982-11-29
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE STEP FREE-T4 125I RADIOIMMUNO- 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 1982-11-29 under 510(k) number K823144. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE STEP FREE-T4 125I RADIOIMMUNO-?

SINGLE STEP FREE-T4 125I RADIOIMMUNO- is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Corning Medical & Scientific. The 510(k) number is K823144.

When did SINGLE STEP FREE-T4 125I RADIOIMMUNO- receive FDA 510(k) clearance?

SINGLE STEP FREE-T4 125I RADIOIMMUNO- received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823144.

Who is the listed applicant for SINGLE STEP FREE-T4 125I RADIOIMMUNO-?

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 SINGLE STEP FREE-T4 125I RADIOIMMUNO-?

The FDA product code for SINGLE STEP FREE-T4 125I RADIOIMMUNO- is CEC.

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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 PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, Inc.

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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