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510(k) K062626

CORTISOL ELISA by Ibl-Hamburg GmbH — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2006
Date Received
September 5, 2006
Clearance Type
Traditional
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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  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
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  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (February 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K010790 — CORTISOL LIA (January 29, 2002)