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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

K123763 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems , Ltd. for the device "IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS". The FDA issued a decision of Substantially Equivalent on December 24, 2013. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. Immunodiagnostic Systems , Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Immunodiagnostic Systems , Ltd.

  • K202136 — IDS Cortisol (April 13, 2021)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K190121 — IDS SHBG (June 17, 2019)
  • K161158 — IDS-iSYS Intact PTHN (January 31, 2017)
  • K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (November 15, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K143324 — IDS-iSYS CTX-I Calibration Verifiers (March 30, 2015)
  • K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)

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)

FDA data resources