510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150528Substantially Equivalent

Cortisol Saliva Luminescence Immunoassay

Ibl International GmbH, Hamburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150528 is the FDA 510(k) clearance record for Cortisol Saliva Luminescence Immunoassay, a class II device, cleared for Ibl International GmbH 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 one 510(k) clearance for Ibl International GmbH. As of , FDA records show one recall naming K150528.

Clearance record

Decision date
Received
(268 days to decision)
Product code
NHG Enzyme Immunoassay, Cortisol, Salivary
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ibl International GmbH Flughafenstrasse 52 A, Hamburg, DE
510(k) summary
Summary PDF
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