510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161251Substantially Equivalent

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

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

K161251 is the FDA 510(k) clearance record for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests, a class II device, cleared for Hangzhou Clongene Biotech Co., Ltd. on under FDA product code DKZ (Enzyme Immunoassay, Amphetamine). FDA records list 9 510(k) clearances for Hangzhou Clongene Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K161251.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DKZ Enzyme Immunoassay, Amphetamine
Regulation
21 CFR 862.3100
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 DKZ

Trailing 12 months

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

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