510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112395Substantially Equivalent

Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test

Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112395 is the FDA 510(k) clearance record for WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST, a class II device, cleared for Guangzhou Wondfo Biotech Co., Ltd. on under FDA product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs). FDA's definition for product code LFG reads: "Intended to measure any of the tricyclic antidepressant drugs in serum or urine". FDA records list 43 510(k) clearances for Guangzhou Wondfo Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K112395.

Clearance record

Decision date
Received
(21 days to decision)
Product code
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Regulation
21 CFR 862.3910
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Guangzhou Wondfo Biotech Co., Ltd. 504 E. Diamond Ave. Suite F, Gaithersburg MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFG

Trailing 12 months

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

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