BIOEASY Multi-Drug Test Cup— 510(k) K182530
Substantially EquivalentShenzhen Bioeasy Biotechnology Co., Ltd.
FDA 510(k) clearance K182530 for BIOEASY Multi-Drug Test Cup, Substantially Equivalent on 2018-11-09. Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Bioeasy Biotechnology Co., Ltd.
- Product code
- Code NFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code NFT
view all- K261409 — BioTeke® Multi-Drug Urine Test Cup
- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
More clearances from Shenzhen Bioeasy Biotechnology Co., Ltd.
view all- K230238 — BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
- K193480 — BIOEASY Multi-Drug Test Cup
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- K192301 — BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
Data sourced from openFDA. This site is unofficial and independent of the FDA.