The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys Aldosterone,ids Isys Aldosterone Control Set, And Ids Isys Aldosterone Calibration Verifiers.
| Device ID | K142994 |
| 510k Number | K142994 |
| Device Name: | IDS-iSYS Aldosterone,IDS ISYS Aldosterone Control Set, And IDS ISYS Aldosterone Calibration Verifiers |
| Classification | Radioimmunoassay, Aldosterone |
| 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 | CJM |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-04-21 |
| Summary: | summary |