Screeners Amphetamine Test, Drugscreen Dip Amphetamine Test
FDA 510(k) K000400 · Drug Detection Devices, Ltd.
510(k) numberK000400
Submission
- Device name
- Screeners Amphetamine Test, Drugscreen Dip Amphetamine Test
- Applicant
- Drug Detection Devices, Ltd.
Alpharetta, GA, US - Received
- February 7, 2000
- Decision date
- April 18, 2000
- 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 |
|---|---|---|
| K000452 | Screeners Methamphetamine Test, Drugscreen Dip Methamphetamine TestLAF · Traditional | 04/24/2000SE |
| K000522 | Screeners Barbiturate Test, Drugscreen Dip Barbiturate TestDIS · Traditional | 04/18/2000SE |
| K000402 | Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) TestLCM · Traditional | 04/18/2000SE |
| K000350 | Screeners Cocaine Test; Drugscreen Dip Cocaine TestDIO · Traditional | 04/11/2000SE |
| K000449 | Screeners Benzodiazepine (BZD) Test, Drug Screen Dip Benzodiazepine (BZD) TestJXM · Traditional | 04/07/2000SE |
| K000273 | Screeners Opiates Test Drugscreen Dip Opiates TestDJG · Traditional | 04/07/2000SE |
| K992949 | Screeners Marijuana Test, Drugscreen Dip Marijuana TestLDJ · Traditional | 12/27/1999SE |
Questions and answers
When was Screeners Amphetamine Test, Drugscreen Dip Amphetamine Test cleared by the FDA?
Screeners Amphetamine Test, Drugscreen Dip Amphetamine Test (K000400) received a 510(k) decision of Substantially Equivalent on April 18, 2000, 71 days after the submission was received.
What is the product code of K000400?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.