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510(k) K011323

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 by Salimetrics, LLC — Product Code NHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2001
Date Received
May 1, 2001
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.

Other clearances by Salimetrics, LLC

  • K051012 — PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MA (July 19, 2005)
  • K031348 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (June 10, 2003)

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)
  • K070788 — ELECSYS CORTISOL TEST SYSTEM (October 5, 2007)
  • 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)