JMO — Ferrozine (Colorimetric) Iron Binding Capacity Class I
FDA product code JMO covers "Ferrozine (Colorimetric) Iron Binding Capacity", a Class I medical device regulated under 21 CFR 862.1415. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- JMO
- Device Class
- Class I
- Regulation Number
- 862.1415
- Submission Type
- 510(k) Exempt
- 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… | Jun 1, 2012 |
| K061464 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120… | Jun 15, 2006 |
| K052867 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Dec 23, 2005 |
| K041793 | Olympus America | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Jul 16, 2004 |
| K013102 | Wiener Laboratories Saic | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT… | Nov 13, 2001 |
| K012340 | Bayer | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Oct 1, 2001 |
| K000781 | Reference Diagnostics | DIRECT TIBC KIT | May 2, 2000 |
| K994115 | Dade Behring | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Jan 28, 2000 |
| K991666 | A.P. Total Care | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | Jun 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 | Feb 16, 1999 |
| K982041 | Abbott Laboratories | UIBC | Jul 30, 1998 |
| K981654 | Abbott Laboratories | TIBC | Jul 22, 1998 |
| K981279 | Abbott Laboratories | TIBC | May 20, 1998 |
| K974604 | Randox Laboratories | RANDOX IRON | Jan 6, 1998 |
| K961587 | Diagnostic Chemicals | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Aug 27, 1996 |
| K963116 | Diagnostic Chemicals | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | Aug 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 | Feb 12, 1996 |
| K946354 | Data Medical Associates | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | May 8, 1995 |