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510(k) K123763

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS by Immunodiagnostic Systems , Ltd. — Product Code CIB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 24, 2013
Date Received: December 7, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radioimmunoassay, Angiotensin I And Renin
Device Class: Class II
Regulation Number: 862.1085
Review Panel: CH
Submission Type

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Other clearances for product code CIB

K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (January 1, 2013)
K062120 — CISBIO RENIN RIA TEST (March 30, 2007)
K061758 — ACTIVE RENIN IRMA (July 28, 2006)
K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AN (September 6, 2001)
K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)
K954299 — BUHLMANN ANGIOSTENSIN II RIA (October 19, 1995)
K940004 — AI-PHOTODIAGNOSTIC (August 4, 1995)
K925998 — ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (January 6, 1993)
K850054 — RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (March 29, 1985)
K842966 — RENIN RADIOIMMUNOASSAY TEST KIT (October 11, 1984)