510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K231978Substantially Equivalent

BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50

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

K231978 is the FDA 510(k) clearance record for BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50, a class II device, cleared for Vivachek Biotech (Hangzhou) Co., Ltd. on under FDA product code NFW (Test, Cannabinoid, 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 K231978.

Clearance record

Decision date
Received
(59 days to decision)
Product code
NFW Test, Cannabinoid, Over The Counter
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd. Floor 2, Block 2, 146 E. Chaofeng Rd., Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFW

Trailing 12 months
1 clearance under product code NFW in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260