Randox Laboratories, Ltd. · Class II · Cleared Sep 9, 1997
| K-number | K972220 |
| Device name | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT |
| Applicant | Randox Laboratories, Ltd. |
| Product code | DHR |
| Device class | Class II |
| Decision date | Sep 9, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.5775 |
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