Agglutex Amphetamine Test Kit
FDA 510(k) K812986 · Hoffmann-La Roche, Inc.
510(k) numberK812986
Submission
- Device name
- Agglutex Amphetamine Test Kit
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- October 26, 1981
- Decision date
- January 22, 1982
- 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 |
| 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 |
More from Hoffmann-La Roche, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was Agglutex Amphetamine Test Kit cleared by the FDA?
Agglutex Amphetamine Test Kit (K812986) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 88 days after the submission was received.
What is the product code of K812986?
The FDA product code is DJP – Radioimmunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.