Modification to Abuscreen Online for Cannabinoids
FDA 510(k) K983701 · Roche Diagnostic Systems, Inc.
510(k) numberK983701
Submission
- Device name
- Modification to Abuscreen Online for Cannabinoids
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- October 21, 1998
- Decision date
- December 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/17/2024SE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…LDJ · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/10/2024SE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
More from Healgen Scientific,, LLC
| 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 |
| 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 |
| K983388 | Ontrak Testcup-ErDIO · Traditional | 11/18/1998SE |
Questions and answers
When was Modification to Abuscreen Online for Cannabinoids cleared by the FDA?
Modification to Abuscreen Online for Cannabinoids (K983701) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 51 days after the submission was received.
What is the product code of K983701?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.