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FDA 510(k)

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

K-Number: K080159 · 2008-05-22

ApplicantKronus Market Development Associates, Inc.
Decision Date2008-05-22
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kronus Market Development Associates, Inc.. It received FDA 510(k) clearance on 2008-05-22 under 510(k) number K080159. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT?

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT is a medical device that received FDA 510(k) clearance on 2008-05-22. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K080159.

When did KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT receive FDA 510(k) clearance?

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT received FDA 510(k) clearance on 2008-05-22, under 510(k) number K080159.

Who is the listed applicant for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT?

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

What is the FDA product code for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT?

The FDA product code for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT is JZO.

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Other records listing Kronus Market Development Associates, 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.

K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITK111956KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITK080523KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITK073590KRONUS IA-2 AUTOANTIBODY RIA ASSAY KITK072135KRONUS GAD AUTOANTIBODY ELISA ASSAY KITK070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

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Related Devices (Code: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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