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FDA 510(k)

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM

K-Number: K022800 · 2002-11-25

ApplicantHyperion, Inc.
Decision Date2002-11-25
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hyperion, Inc.. It received FDA 510(k) clearance on 2002-11-25 under 510(k) number K022800. 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 VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM?

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-25. The listed applicant is Hyperion, Inc.. The 510(k) number is K022800.

When did VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 2002-11-25, under 510(k) number K022800.

Who is the listed applicant for VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM?

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

What is the FDA product code for VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM?

The FDA product code for VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM is DHN.

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Other records listing Hyperion, 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.

K013213HYPERION VISIQUANT ANA TEST KITK935983MICROREADER 4K913809HY-PREP SYSTEMK873138MICRO-READER IIK864060MICRO-READERK855149COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER

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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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