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FDA 510(k)

RADIOIMMUNOASSAY TEST SYSTEM

K-Number: K791096 · 1979-08-03

ApplicantCorning Medical & Scientific
Decision Date1979-08-03
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY TEST SYSTEM 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 1979-08-03 under 510(k) number K791096. The device is classified under product code JMG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOIMMUNOASSAY TEST SYSTEM?

RADIOIMMUNOASSAY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Corning Medical & Scientific. The 510(k) number is K791096.

When did RADIOIMMUNOASSAY TEST SYSTEM receive FDA 510(k) clearance?

RADIOIMMUNOASSAY TEST SYSTEM received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791096.

Who is the listed applicant for RADIOIMMUNOASSAY TEST SYSTEM?

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 RADIOIMMUNOASSAY TEST SYSTEM?

The FDA product code for RADIOIMMUNOASSAY TEST SYSTEM is JMG.

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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: JMG)

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.

K234052Access FerritinBeckman Coulter, Inc.K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.K964282TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.K971833ELECSYS FERRITINBoehringer Mannheim Corp.K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, 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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