Roche Diagnostic Systems, Inc. · Class II · Cleared Jan 3, 1994
| K-number | K935550 |
| Device name | ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | DKB |
| Device class | Class II |
| Decision date | Jan 3, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 862.3200 |
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