Revised Double Antibody Amphetamine
FDA 510(k) K882228 · Diagnostic Products Corp.
510(k) numberK882228
Submission
- Device name
- Revised Double Antibody Amphetamine
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- May 19, 1988
- Decision date
- August 8, 1988
- 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 |
| 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 |
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Questions and answers
When was Revised Double Antibody Amphetamine cleared by the FDA?
Revised Double Antibody Amphetamine (K882228) received a 510(k) decision of Substantially Equivalent on August 8, 1988, 81 days after the submission was received.
What is the product code of K882228?
The FDA product code is DJP – Radioimmunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.