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510(k) K130321

LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS by Diasorin — Product Code CJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2013
Date Received
February 8, 2013
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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Other clearances for product code CJM

  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • 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)