Quickpac II One Step Barbiturate Test
FDA 510(k) K980349 · Syntron Bioresearch, Inc.
510(k) numberK980349
Submission
- Device name
- Quickpac II One Step Barbiturate Test
- Applicant
- Syntron Bioresearch, Inc.
Simi Valley, CA, US - Received
- January 28, 1998
- Decision date
- March 3, 1998
- 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 |
|---|---|---|
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K992990 | Quickpac II One Step Cocaine TestDIO · Traditional | 09/20/1999SE |
| K992748 | Drugcheck X Multidrug Screening DeviceDIO · Traditional | 09/02/1999SE |
| K992207 | Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test SystemDIO · Traditional | 07/22/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | 06/24/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | 11/18/1998SE |
| K981292 | Quikpac II One Step Phencyclidine (PCP) TestLCM · Traditional | 05/26/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | 05/07/1998SE |
| K974712 | Quikstrip One Step Barbiturate TestDIS · Traditional | 02/12/1998SE |
Questions and answers
When was Quickpac II One Step Barbiturate Test cleared by the FDA?
Quickpac II One Step Barbiturate Test (K980349) received a 510(k) decision of Substantially Equivalent on March 3, 1998, 34 days after the submission was received.
What is the product code of K980349?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.