510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102428Substantially Equivalent

Wunder Test

Hien Helen Nguyen, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K102428 is the FDA 510(k) clearance record for WUNDER TEST, a class II device, cleared for Hien Helen Nguyen on under FDA product code LDJ (Enzyme Immunoassay, Cannabinoids). FDA records list one 510(k) clearance for Hien Helen Nguyen. As of , FDA records show no recalls naming K102428.

Clearance record

Decision date
Received
(601 days to decision)
Product code
LDJ Enzyme Immunoassay, Cannabinoids
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Hien Helen Nguyen 1810 Oakland Rd.,, San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code LDJ

Trailing 12 months

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

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