510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K940833Substantially Equivalent

Access(r) Total T3

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

K940833 is the FDA 510(k) clearance record for ACCESS(R) TOTAL T3, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code CDP (Radioimmunoassay, Total Triiodothyronine). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show one recall naming K940833.

Clearance record

Decision date
Received
(196 days to decision)
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Regulation
21 CFR 862.1710
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 CDP

Trailing 12 months

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

FDA records show no clearances under product code CDP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDP, 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