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510(k) K050202

CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS by Beckman Coulter, Inc. — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2005
Date Received
January 28, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

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Other clearances for product code CGR

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  • K062626 — CORTISOL ELISA (December 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
  • K052359 — IBL CORTISOL LIA TEST KIT (October 3, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K010790 — CORTISOL LIA (January 29, 2002)