510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926422Substantially Equivalent

Vista(r) Human Follicle-Stim Hormone(hfsh) Assay

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

K926422 is the FDA 510(k) clearance record for VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY, a class I device, cleared for Syva Co. on under FDA product code GGJ (Fluid, Diluting, White-Cell). FDA records list 59 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K926422.

Clearance record

Decision date
Received
(161 days to decision)
Product code
GGJ Fluid, Diluting, White-Cell
Regulation
21 CFR 864.8200
Device class
Class I
Review panel
Hematology
Applicant
Syva Co. P.O. Box 49013, San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code GGJ

Trailing 12 months

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

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