Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on
FDA 510(k) K973075 · Roche Diagnostic Systems, Inc.
510(k) numberK973075
Submission
- Device name
- Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- August 18, 1997
- Decision date
- October 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
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| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDKZ · Traditional | Xenta Biomedical Science Co., Ltd. | 05/19/2023SE |
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| 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 |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on cleared by the FDA?
Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on (K973075) received a 510(k) decision of Substantially Equivalent on October 9, 1997, 52 days after the submission was received.
What is the product code of K973075?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.