Abuscreen Online TM for Cocaine Metabolite
FDA 510(k) K904995 · Roche Diagnostic Systems, Inc.
510(k) numberK904995
Submission
- Device name
- Abuscreen Online TM for Cocaine Metabolite
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- November 7, 1990
- Decision date
- November 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLN – Radioimmunoassay, Cocaine Metabolite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010868 | Psychemedics Ria Cocaine AssayKLN · Traditional | Psychemedics Corp. | 11/06/2001SE |
| K913867 | Urine Cocaine Metabolite Direct Ria Kit (I-125)KLN · Traditional | Immunalysis Corporation | 09/19/1991SE |
| K913722 | Abuscreen(R) Radioimmun for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 09/10/1991SE |
| K912756 | Abuscreen Radioimmunoassay for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 07/26/1991SE |
| K910123 | Target Cocaine Metabolite-VKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910044 | Milenia Cocaine MetaboliteKLN · Traditional | Diagnostic Products Corp. | 02/13/1991SE |
| K905730 | Abuscreen Ontrak for Cocaine (200NG/ML)KLN · Traditional | Roche Diagnostic Systems, Inc. | 01/15/1991SE |
| K880674 | Micromedic Crackpot Ria KitKLN · Traditional | Icn Micromedic Systems | 10/06/1988SE |
| K871549 | Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]KLN · Traditional | Immunalysis Corporation | 06/16/1987SE |
More from Immunalysis Corporation
| 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 Abuscreen Online TM for Cocaine Metabolite cleared by the FDA?
Abuscreen Online TM for Cocaine Metabolite (K904995) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 21 days after the submission was received.
What is the product code of K904995?
The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.