Ubi Magiwel Amphetamine Metabolites
FDA 510(k) K973153 · United Biotech, Inc.
510(k) numberK973153
Submission
- Device name
- Ubi Magiwel Amphetamine Metabolites
- Applicant
- United Biotech, Inc.
Mountain View, CA, US - Received
- August 22, 1997
- Decision date
- October 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | 09/15/1998SE |
| K973154 | Ubi Magiwel Marijuana MetabolitesLDJ · Traditional | 07/22/1998SE |
| K973692 | Ubi Magiwel C-Reactive Protein(Crp) QuantitativeDCK · Traditional | 02/09/1998SE |
| K973156 | Ubi Magiwel Cocaine MetabolitesDJG · Traditional | 10/28/1997SE |
| K973155 | Ubi Magiwel Opiate MetabolitesDJG · Traditional | 10/28/1997SE |
| K962211 | Ubi Magiwel Thyroxine (T4) QuantitativeKLI · Traditional | 07/08/1996SE |
| K961236 | Ubi Magiwel TRIIODOTHYRONINE(T3) QuantitativeCDP · Traditional | 05/30/1996SE |
| K951993 | Ubi Magiwel Ferritin QuantitativeDBF · Traditional | 07/05/1995SE |
| K924689 | Ubi Magiwel(Tm) Helicobacter Pylori IggLYR · Traditional | 08/10/1993SE |
| K905473 | Ubi Magiwel Cortisol QuantitativeCGR · Traditional | 01/31/1991SE |
Questions and answers
When was Ubi Magiwel Amphetamine Metabolites cleared by the FDA?
Ubi Magiwel Amphetamine Metabolites (K973153) received a 510(k) decision of Substantially Equivalent on October 28, 1997, 67 days after the submission was received.
What is the product code of K973153?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.