IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS— 510(k) K123763
Substantially EquivalentImmunodiagnostic Systems , Ltd.
FDA 510(k) clearance K123763 for IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS, Substantially Equivalent on 2013-12-24. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 2.
Clearance details
- Applicant
- Immunodiagnostic Systems , Ltd.
- Product code
- Code CIB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1085
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boldon, Tyne & Wear, GB
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