FDA 510(k)

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS

K-Number: K050024 · 2005-11-17

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2005-11-17

Product CodeDIS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS 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 2005-11-17 under 510(k) number K050024. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS?

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K050024.

When did ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS receive FDA 510(k) clearance?

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS received FDA 510(k) clearance on 2005-11-17, under 510(k) number K050024.

Who is the listed applicant for ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS?

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 ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS?

The FDA product code for ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS is DIS.

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Official Source

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