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FDA 510(k)

ANA-IFA TEST SYSTEM

K-Number: K803276 · 1981-01-26

ApplicantImmuno Concepts, Inc.
Decision Date1981-01-26
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA-IFA 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 1981-01-26 under 510(k) number K803276. 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 ANA-IFA TEST SYSTEM?

ANA-IFA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K803276.

When did ANA-IFA TEST SYSTEM receive FDA 510(k) clearance?

ANA-IFA TEST SYSTEM received FDA 510(k) clearance on 1981-01-26, under 510(k) number K803276.

Who is the listed applicant for ANA-IFA 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 ANA-IFA TEST SYSTEM?

The FDA product code for ANA-IFA 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-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

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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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