510(k) K881817
- Device
- Abuscreen(r) Ontrak(tm) For Amphetamines
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K881817
- Product code
- DJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-29
- Date received
- 1988-04-28
- Regulation
- 862.3100
- Classification name
- Radioimmunoassay, Amphetamine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ADRIENNE CHOMA
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DJP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960526 | PRIMIDONE EIA TEST | Diagnostic Reagents, Inc. | 1996-03-18 |
| K913866 | URINE AMPHETAMINE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-25 |
| K912755 | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE | Roche Diagnostic Systems, Inc. | 1991-08-26 |
| K882228 | REVISED DOUBLE ANTIBODY AMPHETAMINE | Diagnostic Products Corp. | 1988-08-08 |
| K854009 | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP | Roche Diagnostic Systems, Inc. | 1985-10-15 |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Hoffmann-La Roche, Inc. | 1983-03-24 |
| K823212 | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE | Hoffmann-La Roche, Inc. | 1982-11-29 |
| K812986 | AGGLUTEX AMPHETAMINE TEST KIT | Hoffmann-La Roche, Inc. | 1982-01-22 |