510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922433Substantially Equivalent

Vista Thyroxine (T-4) Assay -- Modification

Syva Co., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922433 is the FDA 510(k) clearance record for VISTA THYROXINE (T-4) ASSAY -- MODIFICATION, a class II device, cleared for Syva Co. on under FDA product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine). FDA records list 59 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K922433.

Clearance record

Decision date
Received
(155 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
Syva Co. 3403 Yerba Buena Rd., San Jose CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLI, 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