One Step Urine Drug of Abuse Barbiturate Test
FDA 510(k) K973047 · Drial Consultants, Inc.
510(k) numberK973047
Submission
- Device name
- One Step Urine Drug of Abuse Barbiturate Test
- Applicant
- Drial Consultants, Inc.
Simi Valley, CA, US - Received
- August 15, 1997
- Decision date
- October 2, 1997
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K973269 | Quikstrip One Step Benzodiazepine TestJXM · Traditional | 02/25/1998SE |
| K973326 | Quikpac II One Step Benzodiazepine TestJXM · Traditional | 02/24/1998SE |
| 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 |
| K971218 | Quikstrip One Step Amphetamine TestDKZ · Traditional | 05/30/1997SE |
| 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 One Step Urine Drug of Abuse Barbiturate Test cleared by the FDA?
One Step Urine Drug of Abuse Barbiturate Test (K973047) received a 510(k) decision of Substantially Equivalent on October 2, 1997, 48 days after the submission was received.
What is the product code of K973047?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.