Glooko Device System for Glooko Logbook+ Application
by Glooko, Inc.
510(k) K130886
Glooko Device System for Glooko Logbook+ Application is a Class II device made by Glooko, Inc., cleared under FDA 510(k) K130886 on 25 Apr 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130886 | Date25 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K130886
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NBW
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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