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510(k) K070788

ELECSYS CORTISOL TEST SYSTEM by Roche Diagnostics — Product Code NHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
March 22, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cortisol, Salivary
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.

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Other clearances for product code NHG

  • K150528 — Cortisol Saliva Luminescence Immunoassay (November 25, 2015)
  • K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (May 8, 2012)
  • K051733 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (December 7, 2005)
  • K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (November 24, 2004)
  • K031348 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (June 10, 2003)
  • K011323 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (December 17, 2001)