Atlas FDA

KQN

8 FDA 510(k) clearances · Product code

93 daysmedian time to decision
182 days90th percentile
8clearances measured

FDA profile

Official device name
Radioassay, Angiotensin Converting Enzyme
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1090
Medical specialty
Clinical Chemistry
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RecordFirmDate
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (K041657)Thermo Electron Corporation2004-08-30
ANGIOTENSIN CONVERTING ENZYME REA (K942497)American Laboratory Products Co., Ltd.1994-11-15
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (K913091)American Laboratory Products Co., Ltd.1991-08-26
ALDOSTERONE DIRECT RIA KIT (K854876)Biotecx Laboratories, Inc.1986-03-17
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (K854245)Sigma Diagnostics, Inc.1986-01-22
ACE COLOR TEST (K833933)Hana Biologics, Inc.1984-03-23
ACE ACTIVITY MICROVIAL TEST SET (K821011)Ventrex Laboratories, Inc.1982-05-03
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (K791712)Ventrex Laboratories, Inc.1979-09-19

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Every clearance here is in the API, with alerts when new ones post.