AssureTech Panel Dip Tests, AssureTech Quick Cup Tests— 510(k) K180349
Substantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearance K180349 for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, Substantially Equivalent on 2018-04-05. Applicant: Assure Tech. (Hangzhou) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. (Hangzhou) 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
- Hangzhou, 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 Assure Tech. (Hangzhou) Co, Ltd.
view all- K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test
- K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Data sourced from openFDA. This site is unofficial and independent of the FDA.