Urine Amphetamines Screen Flex(Tm) Reagent Cartridge
FDA 510(k) K950135 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK950135
Submission
- Device name
- Urine Amphetamines Screen Flex(Tm) Reagent Cartridge
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- January 13, 1995
- Decision date
- March 30, 1995
- 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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|---|---|---|
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional | 07/24/1996SE |
| K953725 | Cronex Radiation Therapy Verification CassetteIXA · Traditional | 09/06/1995SE |
| K953724 | Cronex Radiation Therapy CassetteIXA · Traditional | 09/06/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
| K950137 | Urine Barbiturates Screen Flex(Tm) Reagent CartridgeDIS · Traditional | 04/13/1995SE |
| K950181 | Urine Cannabinoids Screen Flex(Tm) Reagent CartridgeLDJ · Traditional | 04/05/1995SE |
| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| 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 Amphetamines Screen Flex(Tm) Reagent Cartridge cleared by the FDA?
Urine Amphetamines Screen Flex(Tm) Reagent Cartridge (K950135) received a 510(k) decision of Substantially Equivalent on March 30, 1995, 76 days after the submission was received.
What is the product code of K950135?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.