AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup— 510(k) K151211
Substantially EquivalentAssure Tech. Co., Ltd.
FDA 510(k) clearance K151211 for AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup, Substantially Equivalent on 2015-06-04. Applicant: Assure Tech. Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. Co., Ltd.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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More clearances from Assure Tech. Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.