FDA 510(k) Premarket Notification K130055: ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

Submission Details & Decision

Normalized public record details for 510(k) notification K130055.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K130055

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

Product Code

DJG

Decision Date

2013-02-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2013-01-09

Related Establishments / Registrations

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