BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO— 510(k) K992791

Name: FDA 510(k) clearance K992791
Creator: U.S. Food and Drug Administration
Published: 1999-11-12

Substantially Equivalent

Brahms Diagnostica, LLC

FDA 510(k) clearance K992791 for BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO, Substantially Equivalent on 1999-11-12. Applicant: Brahms Diagnostica, LLC. Device class: 2.

Clearance details

Applicant: Brahms Diagnostica, LLC
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1999-08-19
Decision date: 1999-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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