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CFM — Bathophenanthroline, Colorimetry, Iron (Non-Heme) Class I

FDA Device Classification

Classification Details

Product Code
CFM
Device Class
Class I
Regulation Number
862.1410
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K984119wako chemicals usaWAKO L-TYPE FE, WAKO L-TYPE CALIBRATORJanuary 15, 1999
K981581abbott laboratoriesIRONJune 8, 1998
K932871catachemUIBC FOR DISCREET RANDOM ACCESS ANALYZERSeptember 8, 1993
K913705em diagnostic systemsABBOTT QLUICKSTART IRON TEST, ITEM #5A29October 9, 1991
K912912synermedSYNERMED SERUM IRON-600 REAGENT KITJuly 30, 1991
K902918synermedSYNERMED SERUM IRON REAGENT KITJuly 31, 1990
K895047heraeus kulzerCLINISTAT POTASSIUM REAGENT TESTOctober 17, 1989
K891155medical analysis systemsIRON REAGENTApril 18, 1989
K873120abbott laboratoriesABBOTT A-GENT IRON REAGENT KITAugust 25, 1987
K861602data medical associatesTOTAL IRON BINDING CAPACITY PROCEDUREMay 23, 1986
K854305coulter electronicsDART IRON & IRON BINDING CAPACITY REAGENTNovember 12, 1985
K852583data medical associatesDATA CHEM IRON PROCEDUREJuly 12, 1985
K842155diagnostic chemicals, ltd. (usa)SERUM IRON & SERUM IRON BINDING CAPACIAugust 7, 1984
K842505abbott laboratoriesTDX REA IRON DIAGNOSTIC KITAugust 7, 1984
K842156diagnostic chemicals, ltd. (usa)SERUM IRON & SERUM IRON BINDING CAPACITYAugust 7, 1984
K840485somas medical industriesTOTAL IRON UIBC/TIBC ASSAYMarch 12, 1984
K834396seragen diagnosticsDIRECT IRON REAGENT SETFebruary 21, 1984
K830564wako chemicals usaFEB TESTMarch 29, 1983
K820629corning medical and scientificCORNING 902 SODIUM POTASSIUM ANALYZERMarch 25, 1982
K810085bio-analytics laboratoriesIRON KITJanuary 28, 1981