Rapid Response U120
by BTNX Inc
Rapid Response U120 is a Class I device made by BTNX Inc, cleared under FDA 510(k) K070929 on 30 Jul 2007 and listed in FDA GUDID since 16 Oct 2019 (UDI-DI 00722066001936), 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 | Number00722066001936 | Date16 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070929 | Date30 Jul 2007 | StatusActive |
Official records
- AccessGUDID record 00722066001936
- FDA 510(k) database K070929
Across registries
- FDA 510(k) K070929 decided 30 Jul 2007 Active
- FDA GUDID UDI-DI 00722066001936 listed 16 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K070929
- Listed FDA GUDID 00722066001936
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Urine analyser IVD, point-of-care
- Model / reference
- U120
- Primary DI / UDI-DI
- 00722066001936
- 510(k) Number
- FDA product code
- LJX, JRE, JMT, JJB, JIR, JIO, JIN, JIL, CEN, CDM, KQO
- GMDN term
- Urine analyser IVD, point-of-care
- Device class
- Class I
- Regulation number
- 864.7675, 862.2800, 862.1510, 862.1115, 862.1645, 864.6550, 862.1435, 862.1340, 862.1550, 862.1785, 862.2900
- GUDID distribution status
- In Commercial Distribution
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