FDA 510(k)

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)

K-Number: K131754 · 2013-07-31

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2013-07-31

Product CodeDIO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) 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 2013-07-31 under 510(k) number K131754. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)?

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) is a medical device that received FDA 510(k) clearance on 2013-07-31. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K131754.

When did WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) receive FDA 510(k) clearance?

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) received FDA 510(k) clearance on 2013-07-31, under 510(k) number K131754.

Who is the listed applicant for WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)?

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 COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)?

The FDA product code for WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) is DIO.

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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.