Pip Control Solution High PC003-US
Pip Control Solution High PC003-US is a Class I device made by Philosys, Inc., cleared under FDA 510(k) K151658 on 1 Dec 2015 and listed in FDA GUDID since 11 Sep 2020 (UDI-DI 08809301162217), active as of 23 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 | Number08809301162217 | Date11 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151658 | Date1 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 08809301162217
- FDA 510(k) database K151658
Across registries
- FDA 510(k) K151658 decided 1 Dec 2015 Active
- FDA GUDID UDI-DI 08809301162217 listed 11 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K151658
- Listed FDA GUDID 08809301162217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pip Control Solution High
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- PC003-US
- Primary DI / UDI-DI
- 08809301162217
- 510(k) Number
- 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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