Product code JMO— Clinical Chemistry
TIBC
- Classification name
- Ferrozine (Colorimetric) Iron Binding Capacity
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- Advisory panel
- Clinical Chemistry
- Total cleared
- 46
- First cleared
- Most recent
Market context for product code JMO
FDA has cleared devices under product code JMO between 1977 and 2012, filed by 30 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2012
- 2006
- 2005
- 2004
- 2001
- 2000
- 1999
- 1998
- 1996
- 1995
- 1993
- 1992
- 1991
- 1990
- 1989
Top applicants under product code JMO
Recent clearances under product code JMO
- K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
- K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
- K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
- K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
- K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
- K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
- K000781 — DIRECT TIBC KIT
- K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
- K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
- K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02
- K990216 — MAGNETIC TIBC KIT
- K982041 — UIBC
- K981654 — TIBC
- K981279 — TIBC
- K974604 — RANDOX IRON
- K961587 — IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
- K963116 — UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
- K960485 — SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
- K955139 — OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
- K946354 — DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
- K932517 — IRON/UIBC REAGENT
- K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
- K931493 — KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
- K923569 — PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
- K922784 — SYNERMED UIBC REAGENT KIT
- K912716 — J&S IRON REAGENTS
- K912717 — J&S UIBC REAGENTS
- K913922 — ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
- K912795 — BIOTROL UIBC REAGENT
- K904116 — IRON 5 X CONC REAGENT
- K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726
- K893662 — J&S IRON SATURATING REAGENTS
- K883104 — CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
- K881761 — UNSATURATED IRON BINDING CAPACITY
- K880546 — TOTAL IRON BINDING CAPACITY (TIBC)
- K874055 — IRON REAGENT
- K871414 — EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
- K863426 — AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
- K851930 — TDX REA IRON/TIBC
- K851395 — SANDARE IRON-BINDING CAPACITY PROCEDURE
- K850128 — SYSTE MATE TIBC HEM NO. 67225
- K832759 — TOTAL IRON-BINDING CAPACITY ACCESORY
- K831202 — SERUM UIBC-PTF-600 METHOD
- K780094 — IRON BINDING CAPACITY CHEMISTRY
- K771927 — IRON SET, ITEM NO. 65008
- K770748 — TEST, FERROZINE IRON & IRON BINDING
Data sourced from openFDA. This site is unofficial and independent of the FDA.