AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)— 510(k) K152025
Substantially EquivalentAssure Tech. Co., Ltd.
FDA 510(k) clearance K152025 for AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), Substantially Equivalent on 2015-10-05. Applicant: Assure Tech. Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. Co., Ltd.
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- 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.