Quick Screen One Step Amphetamine Test
FDA 510(k) K972577 · Phamatech
510(k) numberK972577
Submission
- Device name
- Quick Screen One Step Amphetamine Test
- Applicant
- Phamatech
San Diego, CA, US - Received
- July 10, 1997
- Decision date
- August 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIT – Thin Layer Chromatography, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910525 | Microline Screen for MethamphetamineDIT · Traditional | Drug Screening Systems, Inc. | 04/05/1991SE |
| K901276 | Hemacon-Doa(Tm) Drugs of Abuse Whole Blood ControlDIT · Traditional | Diagnostic Products Corp. | 04/26/1990SE |
| K790805 | Drug Abuse DipsticksDIT · Traditional | Technical Resources, Inc. | 06/06/1979SE |
More from Technical Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | 10/18/2018SE |
| K131069 | Quickscreen Amphetine 500 TestDKZ · Traditional | 05/14/2014SE |
| K103295 | Quickscreen Cocaine 150 Screening TestDIO · Traditional | 02/01/2012SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | 12/07/2007SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | 02/07/2005SE |
| K043167 | Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XJXM · Special | 12/29/2004SE |
| K041578 | Quickscreen, Models 9177X and 9178XLCM · Special | 09/10/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | 05/20/2004SE |
Questions and answers
When was Quick Screen One Step Amphetamine Test cleared by the FDA?
Quick Screen One Step Amphetamine Test (K972577) received a 510(k) decision of Substantially Equivalent on August 20, 1997, 41 days after the submission was received.
What is the product code of K972577?
The FDA product code is DIT – Thin Layer Chromatography, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.