AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)— 510(k) K152025

Substantially Equivalent

Assure Tech. Co., Ltd.

FDA 510(k) clearance K152025 for AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), Substantially Equivalent on 2015-10-05. Applicant: Assure Tech. Co., Ltd..

Clearance details

Applicant
Assure Tech. Co., Ltd.
Product code
Code DJR
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.