AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)— 510(k) K153465

Name: FDA 510(k) clearance K153465
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Substantially Equivalent

Assure Tech. (Hangzhou) Co, Ltd.

FDA 510(k) clearance K153465 for AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), Substantially Equivalent on 2016-03-31. Applicant: Assure Tech. (Hangzhou) Co, Ltd.. Device class: 2.

Clearance details

Applicant: Assure Tech. (Hangzhou) Co, Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2015-12-01
Decision date: 2016-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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