FIB Calibrator 71-201
FIB Calibrator 71-201 is a Class II device made by r2 Diagnostics Inc., cleared under FDA 510(k) K781880 on 4 Dec 1978 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 10859394006191), 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 | Number10859394006191 | Date15 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK781880 | Date4 Dec 1978 | StatusActive |
Official records
- AccessGUDID record 10859394006191
- FDA 510(k) database K781880
Across registries
- FDA 510(k) K781880 decided 4 Dec 1978 Active
- FDA GUDID UDI-DI 10859394006191 listed 15 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K781880
- Listed FDA GUDID 10859394006191
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FIB Calibrator
- Generic name
- Plasma protein IVD, calibrator
- Model / Ref / Catalog
- 71-201
- Primary DI / UDI-DI
- 10859394006191
- 510(k) Number
- FDA product code
- GIS
- GMDN term
- Plasma protein IVD, calibrator
- Device class
- Class II
- Regulation number
- 864.7340
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Plasma protein IVD, calibrator.