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FDA 510(k)

COLORZYME NDNA TEST SYSTEM

K-Number: K843225 · 1984-11-01

ApplicantImmuno Concepts, Inc.
Decision Date1984-11-01
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COLORZYME NDNA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K843225. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORZYME NDNA TEST SYSTEM?

COLORZYME NDNA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K843225.

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

COLORZYME NDNA TEST SYSTEM received FDA 510(k) clearance on 1984-11-01, under 510(k) number K843225.

Who is the listed applicant for COLORZYME NDNA TEST SYSTEM?

The FDA 510(k) record lists Immuno Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLORZYME NDNA TEST SYSTEM?

The FDA product code for COLORZYME NDNA TEST SYSTEM is DHN.

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Other records listing Immuno Concepts, Inc. as applicant

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Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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