Randox Laboratories, Ltd. · Class II · Cleared Jul 24, 1997
| K-number | K971825 |
| Device name | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST |
| Applicant | Randox Laboratories, Ltd. |
| Product code | JFJ |
| Device class | Class II |
| Decision date | Jul 24, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1070 |
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