Urine Cannabinoids Screen Flex(Tm) Reagent Cartridge
FDA 510(k) K950181 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK950181
Submission
- Device name
- Urine Cannabinoids Screen Flex(Tm) Reagent Cartridge
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- January 17, 1995
- Decision date
- April 5, 1995
- 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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| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | 03/30/1995SE |
| K950427 | Urine Benzodiazepines Screen Flex Teagent CartridgeJXM · Traditional | 03/21/1995SE |
| K950182 | Urine Methadone Screen Flex(Tm) Reagent CartridgeDIW · Traditional | 03/21/1995SE |
| K950134 | Urine Cocaine Metabolite Screen Flex(Tm) Reagent CatridgeDLN · Traditional | 03/21/1995SE |
Questions and answers
When was Urine Cannabinoids Screen Flex(Tm) Reagent Cartridge cleared by the FDA?
Urine Cannabinoids Screen Flex(Tm) Reagent Cartridge (K950181) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 78 days after the submission was received.
What is the product code of K950181?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.