FDA Product Code
FDA Product Code JMO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1415
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 | Traditional | PDF ↗ |
| K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | Ortho-Clinical Diagnostics, Inc. | 2006-06-15 | Special | PDF ↗ |
| K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Olympus America, Inc. | 2004-07-16 | Special | PDF ↗ |
| K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | Wiener Laboratories Saic | 2001-11-13 | Traditional | PDF ↗ |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Bayer Corp. | 2001-10-01 | Traditional | PDF ↗ |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | 2000-05-02 | Traditional | PDF ↗ |
| K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-01-28 | Traditional | PDF ↗ |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | 1999-06-30 | Traditional | PDF ↗ |
| K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K990216 | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K982041 | UIBC | Abbott Laboratories | 1998-07-30 | Traditional | PDF ↗ |
| K981654 | TIBC | Abbott Laboratories | 1998-07-22 | Traditional | PDF ↗ |
| K981279 | TIBC | Abbott Laboratories | 1998-05-20 | Traditional | PDF ↗ |
| K974604 | RANDOX IRON | Randox Laboratories, Ltd. | 1998-01-06 | Traditional | PDF ↗ |
| K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Diagnostic Chemicals , Ltd. | 1996-08-27 | Traditional | PDF ↗ |
| K963116 | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | Diagnostic Chemicals , Ltd. | 1996-08-20 | Traditional | PDF ↗ |
| K960485 | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | Beckman Instruments, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K955139 | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT | Olympus America, Inc. | 1996-02-12 | Traditional | PDF ↗ |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | 1995-05-08 | Traditional | PDF ↗ |
| K932517 | IRON/UIBC REAGENT | Sigma Diagnostics, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | King Diagnostics, Inc. | 1993-10-22 | Traditional | PDF ↗ |
| K931493 | KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT | Eastman Kodak Company | 1993-05-26 | Traditional | PDF ↗ |
| K923569 | PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT | Baxter Diagnostics, Inc. | 1992-08-26 | Traditional | PDF ↗ |
| K922784 | SYNERMED UIBC REAGENT KIT | Synermed, Inc. | 1992-07-21 | Traditional | PDF ↗ |
| K912716 | J&S IRON REAGENTS | J.S. Medical Assoc. | 1991-09-25 | Traditional | PDF ↗ |
| K912717 | J&S UIBC REAGENTS | J.S. Medical Assoc. | 1991-09-25 | Traditional | PDF ↗ |
| K913922 | ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 | Em Diagnostic Systems, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K912795 | BIOTROL UIBC REAGENT | Biotrol, USA, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K904116 | IRON 5 X CONC REAGENT | Trace Scientific , Ltd. | 1990-09-27 | Traditional | PDF ↗ |
| K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 | American Research Products Co. | 1990-05-31 | Traditional | PDF ↗ |
| K893662 | J&S IRON SATURATING REAGENTS | J.S. Medical Assoc. | 1989-07-20 | Traditional | PDF ↗ |
| K883104 | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) | Technicon Instruments Corp. | 1988-10-25 | Traditional | PDF ↗ |
| K881761 | UNSATURATED IRON BINDING CAPACITY | Data Medical Associates, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880546 | TOTAL IRON BINDING CAPACITY (TIBC) | Boehringer Mannheim Corp. | 1988-03-24 | Traditional | PDF ↗ |
| K874055 | IRON REAGENT | Trace Scientific , Ltd. | 1987-10-28 | Traditional | PDF ↗ |
| K871414 | EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 | Em Diagnostic Systems, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K863426 | AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 | American Research Products Co. | 1986-09-16 | Traditional | PDF ↗ |
| K851930 | TDX REA IRON/TIBC | Abbott Laboratories | 1985-05-24 | Traditional | PDF ↗ |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | Sandare Chemical Co., Inc. | 1985-05-07 | Traditional | PDF ↗ |
| K850128 | SYSTE MATE TIBC HEM NO. 67225 | Em Diagnostic Systems, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K832759 | TOTAL IRON-BINDING CAPACITY ACCESORY | Seragen Diagnostics, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831202 | SERUM UIBC-PTF-600 METHOD | American Monitor Corp. | 1983-05-25 | Traditional | PDF ↗ |
| K780094 | IRON BINDING CAPACITY CHEMISTRY | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K771927 | IRON SET, ITEM NO. 65008 | Harleco | 1977-11-14 | Traditional | PDF ↗ |
| K770748 | TEST, FERROZINE IRON & IRON BINDING | Hycel, Inc. | 1977-06-01 | Traditional | PDF ↗ |
Product code JMO · Class I · Clinical Chemistry. Data: openFDA.