510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K220046Substantially Equivalent

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

Shenzhen Superbio Technology Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220046 is the FDA 510(k) clearance record for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11, a class II device, cleared for Shenzhen Superbio Technology Co., Ltd. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list one 510(k) clearance for Shenzhen Superbio Technology Co., Ltd. As of , FDA records show no recalls naming K220046.

Clearance record

Decision date
Received
(342 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Shenzhen Superbio Technology Co., Ltd. Bldg. B, Xinzheng, 71 Area,, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJG

Trailing 12 months
3 clearances under product code DJG in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DJG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20263
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260