510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250803Substantially Equivalent

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

Anhui Deepblue Medical Technological Co., Ltd., Hefei, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250803 is the FDA 510(k) clearance record for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup, a class II device, cleared for Anhui Deepblue Medical Technological Co., Ltd. on under FDA product code NGL (Test, Opiates, Over The Counter). FDA records list one 510(k) clearance for Anhui Deepblue Medical Technological Co., Ltd. As of , FDA records show no recalls naming K250803.

Clearance record

Decision date
Received
(29 days to decision)
Product code
NGL Test, Opiates, Over The Counter
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Anhui Deepblue Medical Technological Co., Ltd. Pearl Industrial Park, 106 Innovation Ave., Hefei, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGL

Trailing 12 months
1 clearance under product code NGL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NGL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260