Visualine Barbiturates Dipstrip Test
FDA 510(k) K020136 · Sun Biomedical Laboratories, Inc.
510(k) numberK020136
Submission
- Device name
- Visualine Barbiturates Dipstrip Test
- Applicant
- Sun Biomedical Laboratories, Inc.
Blackwood, NJ, US - Received
- January 15, 2002
- Decision date
- March 20, 2002
- 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 |
|---|---|---|
| K023856 | Visualine Methadone DipstriptestDJR · Traditional | 08/25/2003SE |
| K023648 | Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine…LDJ · Traditional | 05/06/2003SE |
| K014089 | Visualine II (Also Known AS Sunline) BarituratesDIS · Traditional | 04/25/2002SE |
| K011499 | Visualine Amphetamine Dipstrip AssayDKZ · Traditional | 07/17/2001SE |
| K010177 | Visualine II (Also Known AS Sunline) Amphetamine AssayDKZ · Traditional | 05/17/2001SE |
| K993485 | Visualine V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine…DIO · Traditional | 12/27/1999SE |
| K983790 | Visualine II (Also Known AS Sunline) PhencyclidineLCM · Traditional | 03/01/1999SE |
| K981314 | Visualine II (Also Known AS Sunline) MethadoneDJR · Traditional | 09/04/1998SE |
| K972032 | Visualine II MethamphetimineDKZ · Traditional | 08/12/1997SE |
| K963606 | Visualine Combo V (Cocaine/Thc) TestLDJ · Traditional | 10/30/1996SE |
Questions and answers
When was Visualine Barbiturates Dipstrip Test cleared by the FDA?
Visualine Barbiturates Dipstrip Test (K020136) received a 510(k) decision of Substantially Equivalent on March 20, 2002, 64 days after the submission was received.
What is the product code of K020136?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.