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510(k) K781504

125I-ALDOSTERONE RIA DIAG. KIT by Abbott Laboratories — Product Code CJM

K781504 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "125I-ALDOSTERONE RIA DIAG. KIT". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code CJM (Radioimmunoassay, Aldosterone), a Class II device regulated under 21 CFR 862.1045. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1978
Date Received
August 30, 1978
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)
  • 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)

FDA data resources