| Record ID | K964355 |
|---|---|
| Device Name | ONTRAK TESTCUP 5 (MODIFICATION) |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LCM · TX |
| Decision Date | Dec 13, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
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