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FDA 510(k)

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

K-Number: K972145 · 1998-02-24

ApplicantImmuno Concepts, Inc.
Decision Date1998-02-24
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEP-2000 FLUORESCENT ANA-RO 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 1998-02-24 under 510(k) number K972145. 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 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM?

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K972145.

When did HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM receive FDA 510(k) clearance?

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM received FDA 510(k) clearance on 1998-02-24, under 510(k) number K972145.

Who is the listed applicant for HEP-2000 FLUORESCENT ANA-RO 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 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM?

The FDA product code for HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM is DHN.

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Other records listing Immuno Concepts, Inc. 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.

K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GK013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK974478IMMUNO CONCEPTS ANCA TEST SYSTEMS

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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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