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510(k) K142994

IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Product Code CJM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 21, 2015
Date Received: October 16, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radioimmunoassay, Aldosterone
Device Class: Class II
Regulation Number: 862.1045
Review Panel: CH
Submission Type

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K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (November 15, 2016)
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K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
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K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)
K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

Other clearances for product code CJM

K130321 — LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBR (April 9, 2013)
K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (June 1, 2005)
K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (July 31, 2003)
K943397 — DSL ACTIVE ALDOSTERONE RIA (DSL 8600) (February 13, 1995)
K921205 — DSL ACTIVE ALDOSTERONE (DSL 8600) (July 10, 1992)
K862204 — RSL (125I) ALDOSTERONE KIT (September 25, 1986)
K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
K831178 — COAT-A-COUNT NO-EXTRACTION ALDOSTERONE (May 27, 1983)
K800775 — ALDOCTK-125 (April 21, 1980)
K781504 — 125I-ALDOSTERONE RIA DIAG. KIT (November 22, 1978)