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510(k) K771526

125 I ALDOSTERONE RIA KIT by Diagnostic Products Corp. — Product Code CJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1977
Date Received
August 8, 1977
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

Other clearances by Diagnostic Products Corp.

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  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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)