Atlas FDA

CHQ

10 FDA 510(k) clearances · Product code

86 daysmedian time to decision
196 days90th percentile
10clearances measured

FDA profile

Official device name
Chromatographic/Fluorometric Method, Catecholamines
Device class
Class I (low risk)
Regulation
21 CFR 862.1165
Medical specialty
Clinical Chemistry
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RecordFirmDate
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA (K051969)Ibl GmbH2005-10-03
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (K032199)Esa, Inc.2004-01-30
PLASMA CATECHOLAMINE KIT (K972167)Bioanalytical Systems, Inc.1997-08-04
MODEL 5500 CEAS (K963938)Esa, Inc.1996-12-26
URINARY METANEPHRINE KIT (K952919)Bioanalytical Systems, Inc.1995-09-06
URINARY CATECHOLAMINE KIT (K943099)Bioanalytical Systems, Inc.1994-10-07
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (K931148)Esa, Inc.1993-06-09
PLASMA CATECHOLAMINES BY HPLC (K894966)Bio-Rad1989-10-25
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (K873371)Bio-Rad1988-01-05
CAT-3 CATECHOLAMINE ASSAY KIT (K855214)Whale Scientific, Inc.1986-03-14

Track CHQ automatically

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