510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926322Substantially Equivalent

Access(r) Cortisol Reagents

Bio-Rad Laboratories Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926322 is the FDA 510(k) clearance record for ACCESS(R) CORTISOL REAGENTS, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code JFT (Fluorometric, Cortisol). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K926322.

Clearance record

Decision date
Received
(161 days to decision)
Product code
JFT Fluorometric, Cortisol
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Rad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code JFT

Trailing 12 months

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

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