AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)— 510(k) K161044

Substantially Equivalent

Assure Tech. (Hangzhou) Co, Ltd.

FDA 510(k) clearance K161044 for AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), Substantially Equivalent on 2016-07-06. Applicant: Assure Tech. (Hangzhou) Co, Ltd..

Clearance details

Applicant
Assure Tech. (Hangzhou) Co, Ltd.
Product code
Code DJC
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.