Standard Human Plasma 10487098
by Siemens Healthcare Diagnostics Products Ltd
Standard Human Plasma 10487098 (ORKL19) 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 24 Sep 2016 (UDI-DI 00842768026812), 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 | Number00842768026812 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023141 | Date16 Jan 2003 | StatusActive |
Official records
- AccessGUDID record 00842768026812
- FDA 510(k) database K023141
Across registries
- FDA 510(k) K023141 decided 16 Jan 2003 Active
- FDA GUDID UDI-DI 00842768026812 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K023141
- Listed FDA GUDID 00842768026812
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- Withdrawn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
- 10487098, ORKL19
- Primary DI / UDI-DI
- 00842768026812
- 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
Similar devices
Other devices filed under FDA product code JPA (SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES).
- COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE by Astral Medical Systems
- POTENS + by Wada, Inc.
- BEHRING FIBRINTIMER A by Behring Diagnostics, Inc.
- BOEHRINGER MANNHEIM COAGUCHEK SYSTEM by Boehringer Mannheim Corp.
- THROMBOPLASTIN - FS by American Dade
- MDA B.30 by BIOMERIEUX, INC.
- TOA MEDICAL ELECTRONICS CA-5000 by Sysmex Corp.
- SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER by SIENCO, INC.
- PLASMA, STANDARDIZED NORMAL by Dade, Baxter Travenol Diagnostics, Inc.
- MODIFIED COATRON II AND COATRON JR. by Astral Medical Systems
Other devices from Siemens Healthcare Diagnostics Products Ltd
See all devices from Siemens Healthcare Diagnostics Products Ltd →