510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011323Substantially Equivalent

High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102

Salimetrics LLC., State College PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011323 is the FDA 510(k) clearance record for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102, a class II device, cleared for Salimetrics, LLC on under FDA product code NHG (Enzyme Immunoassay, Cortisol, Salivary). FDA's definition for product code NHG reads: "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...". FDA records list 3 510(k) clearances for Salimetrics, LLC, from to . As of , FDA records show no recalls naming K011323.

Clearance record

Decision date
Received
(230 days to decision)
Product code
NHG Enzyme Immunoassay, Cortisol, Salivary
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Salimetrics, LLC 101 Innovation Blvd., Suite 302, State College PA
510(k) summary
Summary
Third party review
No

Clearances, product code NHG

Trailing 12 months

FDA records hold no clearances under product code NHG in the trailing twelve months.

FDA records show no clearances under product code NHG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260