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
K944703Substantially Equivalent

Thyroxine Enzyme Immunoassay

Diagnostic Reagents, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944703 is the FDA 510(k) clearance record for THYROXINE ENZYME IMMUNOASSAY, a class II device, cleared for Diagnostic Reagents, Inc. on under FDA product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine). FDA records list 66 510(k) clearances for Diagnostic Reagents, Inc., from to . As of , FDA records show no recalls naming K944703.

Clearance record

Decision date
Received
(77 days to decision)
Product code
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Reagents, Inc. 110 Pioneer Way, Mountain View CA
510(k) summary
Statement
Third party review
No

Clearances, product code KLI

Trailing 12 months

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

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