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FDA 510(k)

FOLATE 125I RADIOIMMUNOASSAY

K-Number: K803060 · 1980-12-22

ApplicantCorning Medical & Scientific
Decision Date1980-12-22
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLATE 125I 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 1980-12-22 under 510(k) number K803060. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLATE 125I RADIOIMMUNOASSAY?

FOLATE 125I RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Corning Medical & Scientific. The 510(k) number is K803060.

When did FOLATE 125I RADIOIMMUNOASSAY receive FDA 510(k) clearance?

FOLATE 125I RADIOIMMUNOASSAY received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803060.

Who is the listed applicant for FOLATE 125I 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 FOLATE 125I RADIOIMMUNOASSAY?

The FDA product code for FOLATE 125I RADIOIMMUNOASSAY is CGN.

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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: CGN)

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.

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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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