Quikstrip One Step Amphetamine Test
FDA 510(k) K971218 · Drial Consultants, Inc.
510(k) numberK971218
Submission
- Device name
- Quikstrip One Step Amphetamine Test
- Applicant
- Drial Consultants, Inc.
Simi Valley, CA, US - Received
- April 2, 1997
- Decision date
- May 30, 1997
- 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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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973269 | Quikstrip One Step Benzodiazepine TestJXM · Traditional | 02/25/1998SE |
| K973326 | Quikpac II One Step Benzodiazepine TestJXM · Traditional | 02/24/1998SE |
| K973047 | One Step Urine Drug of Abuse Barbiturate TestDIS · Traditional | 10/02/1997SE |
| K972059 | Quikpac II One Step Cocaine TestDIO · Traditional | 08/28/1997SE |
| K972571 | Quikstrip One Step Opiates TestDJG · Traditional | 08/20/1997SE |
| K972405 | Quikpac II One Step Opiate TestDJG · Traditional | 08/08/1997SE |
| K971926 | Quikstrip One Step Cocaine TestDIO · Traditional | 07/14/1997SE |
| K970395 | Quikstrip One Step MethamphetamineDKZ · Traditional | 06/26/1997SE |
| K971109 | Quikpac II One Step Amphetamine TestDKZ · Traditional | 05/14/1997SE |
| K970724 | Quickpac II One Step Methamphetamine TestDKZ · Traditional | 05/13/1997SE |
Questions and answers
When was Quikstrip One Step Amphetamine Test cleared by the FDA?
Quikstrip One Step Amphetamine Test (K971218) received a 510(k) decision of Substantially Equivalent on May 30, 1997, 58 days after the submission was received.
What is the product code of K971218?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.