Primidone Eia Test
FDA 510(k) K960526 · Diagnostic Reagents, Inc.
510(k) numberK960526
Submission
- Device name
- Primidone Eia Test
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- February 6, 1996
- Decision date
- March 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K854009 | Abuscreen Radioimmunoassay for Amphetamine-High SPDJP · Traditional | Roche Diagnostic Systems, Inc. | 10/15/1985SE |
| 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 |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Primidone Eia Test cleared by the FDA?
Primidone Eia Test (K960526) received a 510(k) decision of Substantially Equivalent on March 18, 1996, 41 days after the submission was received.
What is the product code of K960526?
The FDA product code is DJP – Radioimmunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.