Assure Titanium Blood Glucose Monitoring System— 510(k) K200788
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K200788 for Assure Titanium Blood Glucose Monitoring System, Substantially Equivalent on 2022-05-23. Applicant: Arkray, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code PZI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Kamigyo-Ku, JP
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