Alko Diagnostic Corp. · Class II · Cleared Jun 16, 1997
| K-number | K972004 |
| Device name | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS |
| Applicant | Alko Diagnostic Corp. |
| Product code | CGZ |
| Device class | Class II |
| Decision date | Jun 16, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1170 |
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