510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241869Substantially Equivalent

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

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

K241869 is the FDA 510(k) clearance record for BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader, a class II device, cleared for Vivachek Biotech (Hangzhou) Co., Ltd. on under FDA product code NGL (Test, Opiates, Over The Counter). FDA records list 10 510(k) clearances for Vivachek Biotech (Hangzhou) Co., Ltd., from to . As of , FDA records show no recalls naming K241869.

Clearance record

Decision date
Received
(99 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
Vivachek Biotech (Hangzhou) Co., Ltd. Level 2, Block 2, 146 E. Chaofeng Rd.,, Hangzhou, 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