ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card— 510(k) K201494

Name: FDA 510(k) clearance K201494
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Substantially Equivalent

Advin Biotech, Inc.

FDA 510(k) clearance K201494 for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, Substantially Equivalent on 2020-09-17. Applicant: Advin Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Advin Biotech, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2020-06-05
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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