510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926342Substantially Equivalent

Vista(r) Human Chorionic Gonadotropin (Hcg) Assay

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

K926342 is the FDA 510(k) clearance record for VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY, a class II device, cleared for Syva Co. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 59 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K926342.

Clearance record

Decision date
Received
(62 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
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 JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, 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 20261
October 20260