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FDA 510(k)

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY

K-Number: K990916 · 1999-04-21

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

Device Summary

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA 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 K990916. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY?

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA 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 K990916.

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

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY received FDA 510(k) clearance on 1999-04-21, under 510(k) number K990916.

Who is the listed applicant for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA 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-NATIVE DNA IGG ANTIBODY?

The FDA product code for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY is KTL.

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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 SYSTEMK990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES 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: KTL)

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.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, Inc.

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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