Advin Multi-Drug Screen Test Cassette, Dip Card and Cup— 510(k) K122809

Name: FDA 510(k) clearance K122809
Creator: U.S. Food and Drug Administration
Published: 2013-06-17

Substantially Equivalent

Advin Biotech

FDA 510(k) clearance K122809 for Advin Multi-Drug Screen Test Cassette, Dip Card and Cup, Substantially Equivalent on 2013-06-17. Applicant: Advin Biotech. Device class: 2.

Clearance details

Applicant: Advin Biotech
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2012-09-13
Decision date: 2013-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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