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
K860421Substantially Equivalent

Strat Total Thyroxine Fluoromet Enzyme Immunoassay

American Dade, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860421 is the FDA 510(k) clearance record for STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY, a class II device, cleared for American Dade on under FDA product code CDX (Radioimmunoassay, Total Thyroxine). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K860421.

Clearance record

Decision date
Received
(7 days to decision)
Product code
CDX Radioimmunoassay, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
American Dade P.O. Box 25101, Santa Ana CA
Third party review
No

Clearances, product code CDX

Trailing 12 months

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

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