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FDA 510(k)

VITAMIN B12 FOLATE RADIOASSAY

K-Number: K802037 · 1980-11-21

ApplicantCorning Medical & Scientific
Decision Date1980-11-21
Product CodeCCN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITAMIN B12 FOLATE RADIOASSAY 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 1980-11-21 under 510(k) number K802037. The device is classified under product code CCN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAMIN B12 FOLATE RADIOASSAY?

VITAMIN B12 FOLATE RADIOASSAY is a medical device that received FDA 510(k) clearance on 1980-11-21. The listed applicant is Corning Medical & Scientific. The 510(k) number is K802037.

When did VITAMIN B12 FOLATE RADIOASSAY receive FDA 510(k) clearance?

VITAMIN B12 FOLATE RADIOASSAY received FDA 510(k) clearance on 1980-11-21, under 510(k) number K802037.

Who is the listed applicant for VITAMIN B12 FOLATE RADIOASSAY?

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 VITAMIN B12 FOLATE RADIOASSAY?

The FDA product code for VITAMIN B12 FOLATE RADIOASSAY is CCN.

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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: CCN)

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.

K934945FLOWMETER NIPPLE ADAPTORCardio-Search , Ltd.K920783OXYGEN FLOW CONTROLLERPuritan Bennett Corp.K872038NEB-U-VENTDesign Technologies, Inc.K871262MODIFIED NOFLO IDesign Technologies, Inc.K863613NO-FLO IDesign Technologies, Inc.K863659FLOW INTERRUPTION INDICATORSalter Labs

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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