HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102— 510(k) K011323

Name: FDA 510(k) clearance K011323
Creator: U.S. Food and Drug Administration
Published: 2001-12-17

Substantially Equivalent

Salimetrics, LLC

FDA 510(k) clearance K011323 for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102, Substantially Equivalent on 2001-12-17. Applicant: Salimetrics, LLC. Device class: 2.

Clearance details

Applicant: Salimetrics, LLC
Product code: Code NHG
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2001-05-01
Decision date: 2001-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: State College, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHG

view all

K150528 — Cortisol Saliva Luminescence Immunoassay2015-11-25
K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY2012-05-08
K070788 — ELECSYS CORTISOL TEST SYSTEM2007-10-05
K051733 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL2005-12-07
K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE2004-11-24

More clearances from Salimetrics, LLC

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.