Panels › Clinical Chemistry › Product code JMO · Class 1
Ferrozine (Colorimetric) Iron Binding Capacity
Regulation 862.1415
0510(k)s in 12 months (46 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in JMO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2012 | K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | JMO |
| Jun 15, 2006 | K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 Ortho-Clinical Diagnostics, Inc. | JMO |
| Dec 23, 2005 | K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT Ortho-Clinical Diagnostics, Inc. | JMO |
| Jul 16, 2004 | K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 Olympus America, Inc. | JMO |
| Nov 13, 2001 | K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 Wiener Laboratories Saic, AR | JMO |
| Oct 1, 2001 | K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) Bayer Corp. | JMO |
| May 2, 2000 | K000781 | DIRECT TIBC KIT Reference Diagnostics, Inc. | JMO |
| Jan 28, 2000 | K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE Dade Behring, Inc. | JMO |
| Jun 30, 1999 | K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 A.P. Total Care, Inc. | JMO |
| May 25, 1999 | K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 A.P. Total Care, Inc. | JMO |
| Feb 16, 1999 | K990216 | MAGNETIC TIBC KIT Reference Diagnostics, Inc. | JMO |
| Jul 30, 1998 | K982041 | UIBC Abbott Laboratories | JMO |
| Jul 22, 1998 | K981654 | TIBC Abbott Laboratories | JMO |
| May 20, 1998 | K981279 | TIBC Abbott Laboratories | JMO |
| Jan 6, 1998 | K974604 | RANDOX IRON Randox Laboratories, Ltd., IE | JMO |
| Aug 27, 1996 | K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 Diagnostic Chemicals , Ltd., CA | JMO |
| Aug 20, 1996 | K963116 | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY Diagnostic Chemicals , Ltd., CA | JMO |
| May 10, 1996 | K960485 | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS Beckman Instruments, Inc. | JMO |
| Feb 12, 1996 | K955139 | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT Olympus America, Inc. | JMO |
| May 8, 1995 | K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE Data Medical Associates, Inc. | JMO |
| Nov 9, 1993 | K932517 | IRON/UIBC REAGENT Sigma Diagnostics, Inc. | JMO |
| Oct 22, 1993 | K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT King Diagnostics, Inc. | JMO |
| May 26, 1993 | K931493 | KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT Eastman Kodak Company | JMO |
| Aug 26, 1992 | K923569 | PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT Baxter Diagnostics, Inc. | JMO |
| Jul 21, 1992 | K922784 | SYNERMED UIBC REAGENT KIT Synermed, Inc., CA | JMO |
| Sep 25, 1991 | K912717 | J&S UIBC REAGENTS J.S. Medical Assoc. | JMO |
| Sep 25, 1991 | K912716 | J&S IRON REAGENTS J.S. Medical Assoc. | JMO |
| Sep 19, 1991 | K913922 | ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 Em Diagnostic Systems, Inc. | JMO |
| Aug 12, 1991 | K912795 | BIOTROL UIBC REAGENT Biotrol, USA, Inc. | JMO |
| Sep 27, 1990 | K904116 | IRON 5 X CONC REAGENT Trace Scientific , Ltd., AU | JMO |
| May 31, 1990 | K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 American Research Products Co. | JMO |
| Jul 20, 1989 | K893662 | J&S IRON SATURATING REAGENTS J.S. Medical Assoc. | JMO |
| Oct 25, 1988 | K883104 | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) Technicon Instruments Corp. | JMO |
| Jul 8, 1988 | K881761 | UNSATURATED IRON BINDING CAPACITY Data Medical Associates, Inc. | JMO |
| Mar 24, 1988 | K880546 | TOTAL IRON BINDING CAPACITY (TIBC) Boehringer Mannheim Corp. | JMO |
| Oct 28, 1987 | K874055 | IRON REAGENT Trace Scientific , Ltd., AU | JMO |
| Apr 23, 1987 | K871414 | EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 Em Diagnostic Systems, Inc. | JMO |
| Sep 16, 1986 | K863426 | AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 American Research Products Co. | JMO |
| May 24, 1985 | K851930 | TDX REA IRON/TIBC Abbott Laboratories | JMO |
| May 7, 1985 | K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE Sandare Chemical Co., Inc. | JMO |
| Feb 1, 1985 | K850128 | SYSTE MATE TIBC HEM NO. 67225 Em Diagnostic Systems, Inc. | JMO |
| Oct 14, 1983 | K832759 | TOTAL IRON-BINDING CAPACITY ACCESORY Seragen Diagnostics, Inc. | JMO |
| May 25, 1983 | K831202 | SERUM UIBC-PTF-600 METHOD American Monitor Corp. | JMO |
| Feb 13, 1978 | K780094 | IRON BINDING CAPACITY CHEMISTRY Harleco | JMO |
| Nov 14, 1977 | K771927 | IRON SET, ITEM NO. 65008 Harleco | JMO |
| Jun 1, 1977 | K770748 | TEST, FERROZINE IRON & IRON BINDING Hycel, Inc. | JMO |
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