510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180255Substantially Equivalent

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180255 is the FDA 510(k) clearance record for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, a class II device, cleared for Hangzhou Clongene Biotech Co., Ltd. on under FDA product code PTH (Test, Barbiturate, Over The Counter). FDA's definition for product code PTH reads: "The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine". FDA records list 9 510(k) clearances for Hangzhou Clongene Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K180255.

Clearance record

Decision date
Received
(29 days to decision)
Product code
PTH Test, Barbiturate, Over The Counter
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Hangzhou Clongene Biotech Co., Ltd. Bldg. 4, #20 Longquan Rd., Yuhang District, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTH

Trailing 12 months

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

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