Standard Human Plasma 10873907
by Siemens Healthcare Diagnostics Products Ltd
Standard Human Plasma 10873907 is a Class II device made by Siemens Healthcare Diagnostics Products Ltd, cleared under FDA 510(k) K023141 on 16 Jan 2003 and listed in FDA GUDID since 25 Mar 2024 (UDI-DI 00630414639772), 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 | Number00630414639772 | Date25 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023141 | Date16 Jan 2003 | StatusActive |
Official records
- AccessGUDID record 00630414639772
- FDA 510(k) database K023141
Across registries
- FDA 510(k) K023141 decided 16 Jan 2003 Active
- FDA GUDID UDI-DI 00630414639772 listed 25 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K023141
- Listed FDA GUDID 00630414639772
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Standard Human Plasma
- Generic name
- Multiple coagulation marker IVD, calibrator
- Model / Ref / Catalog
- 10873907
- Primary DI / UDI-DI
- 00630414639772
- 510(k) Number
- FDA product code
- JPA
- GMDN term
- Multiple coagulation marker IVD, calibrator
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution
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