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FDA 510(k)

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

K-Number: K001556 · 2000-08-21

ApplicantThe Binding Site, Ltd.
Decision Date2000-08-21
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 2000-08-21 under 510(k) number K001556. 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-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY?

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2000-08-21. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K001556.

When did HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY receive FDA 510(k) clearance?

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY received FDA 510(k) clearance on 2000-08-21, under 510(k) number K001556.

Who is the listed applicant for HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY?

The FDA 510(k) record lists The Binding Site, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY?

The FDA product code for HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY is DHN.

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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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