FDA 510(k)

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

K-Number: K130055 · 2013-02-14

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2013-02-14

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K130055. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON BUP ONE STEP BUPRENORPHINE TEST STRIP?

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K130055.

When did ACON BUP ONE STEP BUPRENORPHINE TEST STRIP receive FDA 510(k) clearance?

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP received FDA 510(k) clearance on 2013-02-14, under 510(k) number K130055.

Who is the listed applicant for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP?

The FDA product code for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP is DJG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.