Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests
FDA 510(k) K973784 · Biosite Incorporated
510(k) numberK973784
Submission
- Device name
- Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- October 3, 1997
- Decision date
- December 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 12/13/2023SE |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDKZ · Traditional | Xenta Biomedical Science Co., Ltd. | 05/19/2023SE |
| K200363 | Quidel Triage® TOX Drug Screen, 94600DKZ · Special | Quidel Cardiovascular, Inc. | 03/11/2020SE |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelDKZ · Traditional | Atlas Medical | 10/03/2019SE |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ · Traditional | Quidel Cardiovascular, Inc. | 06/19/2019SE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 03/27/2019SE |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…DKZ · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/14/2018SE |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | Phamatech, Inc. | 10/18/2018SE |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | Alfa Scientific Designs, Inc. | 02/23/2018SE |
More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092987 | INRATIO/INRATIO2 Test StripsGJS · Traditional | 06/11/2010SE |
| K092048 | One Step Eddp (Methadone Metabolite) Test StripDJR · Traditional | 04/19/2010SE |
| K093032 | Triage Total 3 Controls and Calibration Verification SetJJY · Traditional | 11/13/2009SE |
| K080269 | Triage Cardioprofiler and Profiler S.O.B. PanelsNBC · Traditional | 06/06/2008SE |
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5JJY · Traditional | 12/07/2007SE |
| K062840 | Triage Protein C Controls and Calibration Verification ControlsGGN · Traditional | 03/01/2007SE |
| K062530 | Triage Protein C TestGGP · Traditional | 01/29/2007SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | 07/10/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | 06/22/2006SE |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | 01/23/2006SE |
Questions and answers
When was Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests cleared by the FDA?
Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests (K973784) received a 510(k) decision of Substantially Equivalent on December 3, 1997, 61 days after the submission was received.
What is the product code of K973784?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.