Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test
FDA 510(k) K000522 · Drug Detection Devices, Ltd.
510(k) numberK000522
Submission
- Device name
- Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test
- Applicant
- Drug Detection Devices, Ltd.
Alpharetta, GA, US - Received
- February 16, 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
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
More from Phamatech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000452 | Screeners Methamphetamine Test, Drugscreen Dip Methamphetamine TestLAF · Traditional | 04/24/2000SE |
| K000402 | Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) TestLCM · Traditional | 04/18/2000SE |
| K000400 | Screeners Amphetamine Test, Drugscreen Dip Amphetamine TestDKZ · 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 Barbiturate Test, Drugscreen Dip Barbiturate Test cleared by the FDA?
Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test (K000522) received a 510(k) decision of Substantially Equivalent on April 18, 2000, 62 days after the submission was received.
What is the product code of K000522?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.