Fe SI3821
Fe SI3821 is a Class I device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K974604 on 6 Jan 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273206210), 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 | Number05055273206210 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974604 | Date6 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 05055273206210
- FDA 510(k) database K974604
Across registries
- FDA 510(k) K974604 decided 6 Jan 1998 Active
- FDA GUDID UDI-DI 05055273206210 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K974604
- Listed FDA GUDID 05055273206210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fe
- Generic name
- Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
- Model / Ref / Catalog
- SI3821
- Primary DI / UDI-DI
- 05055273206210
- 510(k) Number
- FDA product code
- JMO
- GMDN term
- Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
- Device class
- Class I
- Regulation number
- 862.1415
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity).
- TIBC by Abbott Laboratories
- IRON REAGENT by Trace Scientific, Ltd.
- J&S UIBC REAGENTS by J.S. Medical Assoc.
- TOTAL IRON, MODELS FE 109-01, FE 109-02 by A.P. Total Care, Inc.
- IRON BINDING CAPACITY CHEMISTRY by Harleco
- IRON REAGENTS PRODUCT CODES 7725 AND 7726 by American Research Products Co.
- SANDARE IRON-BINDING CAPACITY PROCEDURE by Sandare Chemical Co., Inc.
- UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY by Diagnostic Chemicals, Ltd.
- BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) by Bayer Corp.