510(k) K912754
- Device
- Abuscreen Radioimmunoassay For Methamphetamine
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K912754
- Product code
- DPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-27
- Date received
- 1991-06-21
- Regulation
- 862.3100
- Classification name
- Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL KRIEGER
- 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 DPJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K913911 | ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET | Roche Diagnostic Systems, Inc. | 1991-11-01 |