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FDA Product Code

FDA Product Code KQN — Clearance Directory

Device Class
Class II
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1090

510(k) Clearances — 8 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K041657 THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT Thermo Electron Corporation 2004-08-30 Traditional PDF ↗
K942497 ANGIOTENSIN CONVERTING ENZYME REA American Laboratory Products Co., Ltd. 1994-11-15 Traditional PDF ↗
K913091 BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY American Laboratory Products Co., Ltd. 1991-08-26 Traditional PDF ↗
K854876 ALDOSTERONE DIRECT RIA KIT Biotecx Laboratories, Inc. 1986-03-17 Traditional PDF ↗
K854245 SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV Sigma Diagnostics, Inc. 1986-01-22 Traditional PDF ↗
K833933 ACE COLOR TEST Hana Biologics, Inc. 1984-03-23 Traditional PDF ↗
K821011 ACE ACTIVITY MICROVIAL TEST SET Ventrex Laboratories, Inc. 1982-05-03 Traditional PDF ↗
K791712 ANGIOTENSIN CONVERTING ENZYME ASSAY SYS Ventrex Laboratories, Inc. 1979-09-19 Traditional PDF ↗

Product code KQN · Class II · Clinical Chemistry. Data: openFDA.