Urine Amphetamine Direct Ria Kit (I-125)
FDA 510(k) K913866 · Immunalysis Corporation
510(k) numberK913866
Submission
- Device name
- Urine Amphetamine Direct Ria Kit (I-125)
- Applicant
- Immunalysis Corporation
Glendale, CA, US - Received
- August 27, 1991
- Decision date
- September 25, 1991
- 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 |
|---|---|---|---|
| K960526 | Primidone Eia TestDJP · Traditional | Diagnostic Reagents, Inc. | 03/18/1996SE |
| 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 |
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Questions and answers
When was Urine Amphetamine Direct Ria Kit (I-125) cleared by the FDA?
Urine Amphetamine Direct Ria Kit (I-125) (K913866) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 29 days after the submission was received.
What is the product code of K913866?
The FDA product code is DJP – Radioimmunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.