FDA 510(k)

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST

K-Number: K113624 · 2012-03-12

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2012-03-12

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST 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 2012-03-12 under 510(k) number K113624. 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 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST?

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST is a medical device that received FDA 510(k) clearance on 2012-03-12. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K113624.

When did WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST receive FDA 510(k) clearance?

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST received FDA 510(k) clearance on 2012-03-12, under 510(k) number K113624.

Who is the listed applicant for WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST?

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 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST?

The FDA product code for WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST is DJG.

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Other records listing Guangzhou Wondfo Biotech Co., Ltd. as applicant

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Official Source

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