KQN — Radioassay, Angiotensin Converting Enzyme Class II

FDA Device Classification

Classification Details

Product Code
KQN
Device Class
Class II
Regulation Number
862.1090
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K041657thermo electron corporationTHERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENTAugust 30, 2004
K942497american laboratory products coANGIOTENSIN CONVERTING ENZYME REANovember 15, 1994
K913091american laboratory products coBUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYAugust 26, 1991
K854876biotecx laboratoriesALDOSTERONE DIRECT RIA KITMarch 17, 1986
K854245sigma diagnosticsSIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVJanuary 22, 1986
K833933hana biologicsACE COLOR TESTMarch 23, 1984
K821011ventrex laboratoriesACE ACTIVITY MICROVIAL TEST SETMay 3, 1982
K791712ventrex laboratoriesANGIOTENSIN CONVERTING ENZYME ASSAY SYSSeptember 19, 1979