Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test
FDA 510(k) K121557 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK121557
Submission
- Device name
- Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- May 25, 2012
- Decision date
- July 25, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT · Traditional | 09/25/2020SE |
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| K173229 | Preview Digital Pregnancy TestLCX · Traditional | 03/12/2018SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | 05/14/2017SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | 06/27/2016SE |
Questions and answers
When was Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test cleared by the FDA?
Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test (K121557) received a 510(k) decision of Substantially Equivalent on July 25, 2012, 61 days after the submission was received.
What is the product code of K121557?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.