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 |