AssureTech Panel Dip Test, AssureTech Quick Cup Test— 510(k) K170049
Substantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearance K170049 for AssureTech Panel Dip Test, AssureTech Quick Cup Test, Substantially Equivalent on 2017-05-02. 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.