510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043175Substantially Equivalent

Elecsys Cortisol Test System, Addition of Saliva Sample Type

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043175 is the FDA 510(k) clearance record for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE, a class II device, cleared for Roche Diagnostics Corp. 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 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show one recall naming K043175.

Clearance record

Decision date
Received
(8 days to decision)
Product code
NHG Enzyme Immunoassay, Cortisol, Salivary
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
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