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FDA 510(k)

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

K-Number: K992790 · 1999-11-12

ApplicantBrahms Diagnostica, LLC
Decision Date1999-11-12
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG is the device name listed in this FDA 510(k) record. The listed applicant is Brahms Diagnostica, LLC. It received FDA 510(k) clearance on 1999-11-12 under 510(k) number K992790. 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 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG?

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is Brahms Diagnostica, LLC. The 510(k) number is K992790.

When did BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG receive FDA 510(k) clearance?

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG received FDA 510(k) clearance on 1999-11-12, under 510(k) number K992790.

Who is the listed applicant for BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG?

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

What is the FDA product code for BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG?

The FDA product code for BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG is JZO.

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Other records listing Brahms Diagnostica, LLC 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.

K033454BRAHMS DIAGNOSTICA LUMITEST TRAK HUMANK021057BRAHMS DIAGNOSTICA DYNOTEST TG-PLUSK000287BRAHMS DIAGNOSTICA LUMITEST ANTI-TPOK000286BRAHMS DIAGNOSTICA LUMITEST ANTI-TGK992791BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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