Abuscreen Radioimmunoassay for Amphetamine-High SP
FDA 510(k) K854009 · Roche Diagnostic Systems, Inc.
510(k) numberK854009
Submission
- Device name
- Abuscreen Radioimmunoassay for Amphetamine-High SP
- Applicant
- Roche Diagnostic Systems, Inc.
Belleville, NJ, US - Received
- September 30, 1985
- Decision date
- October 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJP – Radioimmunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960526 | Primidone Eia TestDJP · Traditional | Diagnostic Reagents, Inc. | 03/18/1996SE |
| K913866 | Urine Amphetamine Direct Ria Kit (I-125)DJP · Traditional | Immunalysis Corporation | 09/25/1991SE |
| K912755 | Abuscreen Radioimmunoassay for AmphetamineDJP · Traditional | Roche Diagnostic Systems, Inc. | 08/26/1991SE |
| K882228 | Revised Double Antibody AmphetamineDJP · Traditional | Diagnostic Products Corp. | 08/08/1988SE |
| K881817 | Abuscreen(R) Ontrak(Tm) for AmphetaminesDJP · Traditional | Roche Diagnostic Systems, Inc. | 07/29/1988SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
| K823212 | Abuscreen Radioimmunoassay - AmphetamineDJP · Traditional | Hoffmann-La Roche, Inc. | 11/29/1982SE |
| K812986 | Agglutex Amphetamine Test KitDJP · Traditional | Hoffmann-La Roche, Inc. | 01/22/1982SE |
More from Hoffmann-La Roche, 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 Abuscreen Radioimmunoassay for Amphetamine-High SP cleared by the FDA?
Abuscreen Radioimmunoassay for Amphetamine-High SP (K854009) received a 510(k) decision of Substantially Equivalent on October 15, 1985, 15 days after the submission was received.
What is the product code of K854009?
The FDA product code is DJP – Radioimmunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.