Randox Laboratories, Ltd. · Class I · Cleared Dec 1, 2011
| K-number | K112337 |
| Device name | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL |
| Applicant | Randox Laboratories, Ltd. |
| Product code | JJY |
| Device class | Class I |
| Decision date | Dec 1, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov