510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922138Substantially Equivalent

Vista Ultrasensitive Htsh Assay

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

K922138 is the FDA 510(k) clearance record for VISTA ULTRASENSITIVE HTSH ASSAY, a class II device, cleared for Syva Co. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 59 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K922138.

Clearance record

Decision date
Received
(96 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
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 JLW

Trailing 12 months
1 clearance under product code JLW in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JLW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260