Ubi Magiwel Marijuana Metabolites
FDA 510(k) K973154 · United Biotech, Inc.
510(k) numberK973154
Submission
- Device name
- Ubi Magiwel Marijuana Metabolites
- Applicant
- United Biotech, Inc.
Mountain View, CA, US - Received
- August 22, 1997
- Decision date
- July 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
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| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | 09/15/1998SE |
| 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 |
| K973153 | Ubi Magiwel Amphetamine 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 Marijuana Metabolites cleared by the FDA?
Ubi Magiwel Marijuana Metabolites (K973154) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 334 days after the submission was received.
What is the product code of K973154?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.