Immunodiagnostic Systems , Ltd. · Class II · Cleared Dec 24, 2013
| K-number | K123763 |
| Device name | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS |
| Applicant | Immunodiagnostic Systems , Ltd. |
| Product code | CIB |
| Device class | Class II |
| Decision date | Dec 24, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 862.1085 |
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