Rapid Response BZO-1C3-40
by BTNX Inc
Rapid Response BZO-1C3-40 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K121065 on 24 May 2013 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066000519), 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 | GUDID listing | Number00722066000519 | Date25 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121065 | Date24 May 2013 | StatusActive |
Official records
- AccessGUDID record 00722066000519
- FDA 510(k) database K121065
Across registries
- FDA 510(k) K121065 decided 24 May 2013 Active
- FDA GUDID UDI-DI 00722066000519 listed 25 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K121065
- Listed FDA GUDID 00722066000519
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- BZO-1C3-40
- Primary DI / UDI-DI
- 00722066000519
- 510(k) Number
- FDA product code
- JXM
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3170
- GUDID distribution status
- In Commercial Distribution
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