Assure Titanium Blood Glucose Monitoring System
FDA 510(k) clearance K200788 · decided 2022-05-23
Clearance details
- K-number
- K200788
- Device name
- Assure Titanium Blood Glucose Monitoring System
- Applicant
- Arkray, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-26
- Decision date
- 2022-05-23
- Days to decision
- 788 days
- Clearance type
- Dual Track
- Product code
- PZI
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Kamigyo-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.