Ortho Diagnostic Systems, Inc. · Class II · Cleared Mar 6, 1997
| K-number | K951632 |
| Device name | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) |
| Applicant | Ortho Diagnostic Systems, Inc. |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Mar 6, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
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