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FDA 510(k)

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

K-Number: K990915 · 1999-04-21

ApplicantStellar Bio Systems, Inc.
Decision Date1999-04-21
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Stellar Bio Systems, Inc.. It received FDA 510(k) clearance on 1999-04-21 under 510(k) number K990915. 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 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY?

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY is a medical device that received FDA 510(k) clearance on 1999-04-21. The listed applicant is Stellar Bio Systems, Inc.. The 510(k) number is K990915.

When did INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY receive FDA 510(k) clearance?

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY received FDA 510(k) clearance on 1999-04-21, under 510(k) number K990915.

Who is the listed applicant for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY?

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

What is the FDA product code for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY?

The FDA product code for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY is DHN.

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Other records listing Stellar Bio Systems, 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.

K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMK990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYK914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYK905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)

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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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