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FDA 510(k)

ANA ANTISERA CONTROL KIT

K-Number: K894659 · 1989-09-21

ApplicantLipogen, Inc.
Decision Date1989-09-21
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA ANTISERA CONTROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lipogen, Inc.. It received FDA 510(k) clearance on 1989-09-21 under 510(k) number K894659. 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 ANTISERA CONTROL KIT?

ANA ANTISERA CONTROL KIT is a medical device that received FDA 510(k) clearance on 1989-09-21. The listed applicant is Lipogen, Inc.. The 510(k) number is K894659.

When did ANA ANTISERA CONTROL KIT receive FDA 510(k) clearance?

ANA ANTISERA CONTROL KIT received FDA 510(k) clearance on 1989-09-21, under 510(k) number K894659.

Who is the listed applicant for ANA ANTISERA CONTROL KIT?

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

What is the FDA product code for ANA ANTISERA CONTROL KIT?

The FDA product code for ANA ANTISERA CONTROL KIT is DHN.

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Other records listing Lipogen, 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.

K902636LIPOGEN RHEUMELISA DSDNA ASSAYK895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESK895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESK895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESK895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESK892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

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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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