AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests— 510(k) K201630
Substantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearance K201630 for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests, Substantially Equivalent on 2021-08-12. Applicant: Assure Tech. (Hangzhou) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- 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.