The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, And Ids Isys Direct Renin Calibration Verifiers.
| Device ID | K123763 |
| 510k Number | K123763 |
| Device Name: | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Mick Fenton |
| Correspondent | Mick Fenton IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-12-24 |