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510(k) K831178

COAT-A-COUNT NO-EXTRACTION ALDOSTERONE by Diagnostic Products Corp. — Product Code CJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
April 11, 1983
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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  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
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  • 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)

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  • 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)
  • K800775 — ALDOCTK-125 (April 21, 1980)
  • K781504 — 125I-ALDOSTERONE RIA DIAG. KIT (November 22, 1978)