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FDA 510(k)

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

K-Number: K021057 · 2002-09-17

ApplicantBrahms Diagnostica, LLC
Decision Date2002-09-17
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS 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 2002-09-17 under 510(k) number K021057. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS?

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Brahms Diagnostica, LLC. The 510(k) number is K021057.

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

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS received FDA 510(k) clearance on 2002-09-17, under 510(k) number K021057.

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

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 TG-PLUS?

The FDA product code for BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS is MSW.

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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 HUMANK000287BRAHMS DIAGNOSTICA LUMITEST ANTI-TPOK000286BRAHMS DIAGNOSTICA LUMITEST ANTI-TGK992791BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPOK992790BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

Related Devices (Code: MSW)

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.

K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K240927Access ThyroglobulinBeckman Coulter, Inc.K241423Access ThyroglobulinBeckman Coulter, Inc.K221890Elecsys Tg IIRoche DiagnosticsK220972Access ThyroglobulinBeckman Coulter, Inc.K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.

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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