Ez-Screen:Barbiturates
FDA 510(k) K905057 · Environmental Diagnostics, Inc.
510(k) numberK905057
Submission
- Device name
- Ez-Screen:Barbiturates
- Applicant
- Environmental Diagnostics, Inc.
Burlington, NC, US - Received
- November 8, 1990
- Decision date
- November 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K905700 | Ez-Screen: AmphetaminesDKZ · Traditional | 01/15/1991SE |
| K902681 | Ez-Screen:HcgJHI · Traditional | 08/09/1990SE |
| K900203 | Ez-Screen:OpiatesDJG · Traditional | 03/09/1990SE |
| K883105 | Ez-Screen Cannabinoid/CocaineDIO · Traditional | 12/16/1988SE |
| K862916 | Ez-Screen: CannabinoidKLT · Traditional | 01/07/1987SE |
Questions and answers
When was Ez-Screen:Barbiturates cleared by the FDA?
Ez-Screen:Barbiturates (K905057) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 20 days after the submission was received.
What is the product code of K905057?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.