ACON BUP ONE STEP BUPRENORPHINE TEST STRIP— 510(k) K130055

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K130055 for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP, Substantially Equivalent on 2013-02-14. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2013-01-09
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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