Roche Diagnostic Systems, Inc. · Class II · Cleared Sep 27, 1991
| K-number | K912754 |
| Device name | ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | DPJ |
| Device class | Class II |
| Decision date | Sep 27, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov