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FDA 510(k)

ASSAY SYSTEM, FERRITIN I KIT

K-Number: K781888 · 1979-01-10

ApplicantNew England Nuclear
Decision Date1979-01-10
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ASSAY SYSTEM, FERRITIN I KIT is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781888. 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 ASSAY SYSTEM, FERRITIN I KIT?

ASSAY SYSTEM, FERRITIN I KIT is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is New England Nuclear. The 510(k) number is K781888.

When did ASSAY SYSTEM, FERRITIN I KIT receive FDA 510(k) clearance?

ASSAY SYSTEM, FERRITIN I KIT received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781888.

Who is the listed applicant for ASSAY SYSTEM, FERRITIN I KIT?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSAY SYSTEM, FERRITIN I KIT?

The FDA product code for ASSAY SYSTEM, FERRITIN I KIT is JMG.

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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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