Walgreens 10170
Walgreens 10170 is a Class II device made by Walgreen Co., cleared under FDA 510(k) K172257 on 22 Dec 2017 and listed in FDA GUDID since 24 Aug 2018 (UDI-DI 00311917198897), 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 | Number00311917198897 | Date24 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172257 | Date22 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 00311917198897
- FDA 510(k) database K172257
Across registries
- FDA 510(k) K172257 decided 22 Dec 2017 Active
- FDA GUDID UDI-DI 00311917198897 listed 24 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K172257
- Listed FDA GUDID 00311917198897
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Walgreens
- Generic name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
- Model / reference
- 10170
- Primary DI / UDI-DI
- 00311917198897
- 510(k) Number
- FDA product code
- LCX
- GMDN term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 5.5 Inch
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