JMO — Ferrozine (Colorimetric) Iron Binding Capacity Class I
FDA Device Classification
Classification Details
- Product Code
- JMO
- Device Class
- Class I
- Regulation Number
- 862.1415
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K113438 | alfa wassermann diagnostic technologies | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, AC | June 1, 2012 |
| K061464 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 | June 15, 2006 |
| K052867 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | December 23, 2005 |
| K041793 | olympus america | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | July 16, 2004 |
| K013102 | wiener laboratories saic | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492 | November 13, 2001 |
| K012340 | bayer | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | October 1, 2001 |
| K000781 | reference diagnostics | DIRECT TIBC KIT | May 2, 2000 |
| K994115 | dade behring | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | January 28, 2000 |
| K991666 | a.p. total care | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | June 30, 1999 |
| K991244 | a.p. total care | TOTAL IRON, MODELS FE 109-01, FE 109-02 | May 25, 1999 |
| K990216 | reference diagnostics | MAGNETIC TIBC KIT | February 16, 1999 |
| K982041 | abbott laboratories | UIBC | July 30, 1998 |
| K981654 | abbott laboratories | TIBC | July 22, 1998 |
| K981279 | abbott laboratories | TIBC | May 20, 1998 |
| K974604 | randox laboratories | RANDOX IRON | January 6, 1998 |
| K961587 | diagnostic chemicals | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | August 27, 1996 |
| K963116 | diagnostic chemicals | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | August 20, 1996 |
| K960485 | beckman instruments | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | May 10, 1996 |
| K955139 | olympus america | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT | February 12, 1996 |
| K946354 | data medical associates | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | May 8, 1995 |