INVADER UGT1A1 MOLECULAR ASSAY— 510(k) K051824

Name: FDA 510(k) clearance K051824
Creator: U.S. Food and Drug Administration
Published: 2005-08-18

Substantially Equivalent

Third Wave Technologies, Inc.

FDA 510(k) clearance K051824 for INVADER UGT1A1 MOLECULAR ASSAY, Substantially Equivalent on 2005-08-18. Applicant: Third Wave Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Third Wave Technologies, Inc.
Product code: Code NTI
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2005-07-05
Decision date: 2005-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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