Rapid Response TSH-13C20
by BTNX Inc
Rapid Response TSH-13C20 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K030912 on 25 Jul 2003 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066001646), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00722066001646 | Date25 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030912 | Date25 Jul 2003 | StatusActive |
Official records
- AccessGUDID record 00722066001646
- FDA 510(k) database K030912
Across registries
- FDA 510(k) K030912 decided 25 Jul 2003 Active
- FDA GUDID UDI-DI 00722066001646 listed 25 Oct 2016 Listed
Recalls
-
- Terminated Z-0646-2007
Positive control showed little or no positive line.
Timeline
- Cleared FDA 510(k) K030912
- Recall initiated FDA recalls Z-0646-2007
- Listed FDA GUDID 00722066001646
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- TSH-13C20
- Primary DI / UDI-DI
- 00722066001646
- 510(k) Number
- FDA product code
- JLW
- GMDN term
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 862.1690
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA).