Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500)
FDA 510(k) K122961 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK122961
Submission
- Device name
- Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500)
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- September 25, 2012
- Decision date
- December 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500) cleared by the FDA?
Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500) (K122961) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 87 days after the submission was received.
What is the product code of K122961?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.