Roche Diagnostic Systems, Inc. · Class I · Cleared Aug 12, 1991
| K-number | K913107 |
| Device name | ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | LAS |
| Device class | Class I |
| Decision date | Aug 12, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.3280 |
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