510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180879Substantially Equivalent

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use

Shanghai Venture Bio-Tech Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180879 is the FDA 510(k) clearance record for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use, a class II device, cleared for Shanghai Venture Bio-Tech Co., Ltd. on under FDA product code DKZ (Enzyme Immunoassay, Amphetamine). FDA records list 2 510(k) clearances for Shanghai Venture Bio-Tech Co., Ltd., from to . As of , FDA records show no recalls naming K180879.

Clearance record

Decision date
Received
(255 days to decision)
Product code
DKZ Enzyme Immunoassay, Amphetamine
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Shanghai Venture Bio-Tech Co., Ltd. Rm. 313, Bldg. 2, # 2715 Longwu Rd., Xuhui District, Shanghai, 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