GlucoTrack Solution Level 2 GT-C02
GlucoTrack Solution Level 2 GT-C02 is a Class I device made by Philosys, Inc., cleared under FDA 510(k) K151658 on 1 Dec 2015 (4 earlier submissions) and listed in FDA GUDID since 16 Aug 2018 (UDI-DI 08809301168066), active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809301168066 | Date16 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151658 | Date1 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 08809301168066
- FDA 510(k) database K151658
- FDA 510(k) database K150299
- FDA 510(k) database K141656
- FDA 510(k) database K131230
- FDA 510(k) database K113636
Across registries
- FDA 510(k) K151658 decided 1 Dec 2015 Active
- FDA GUDID UDI-DI 08809301168066 listed 16 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K113636
- Cleared FDA 510(k) K131230
- Cleared FDA 510(k) K141656
- Cleared FDA 510(k) K150299
- Cleared FDA 510(k) K151658
- Listed FDA GUDID 08809301168066
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GlucoTrack Solution Level 2
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- GT-C02
- Primary DI / UDI-DI
- 08809301168066
- FDA product code
- JJX
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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