Atlas FDA

DEG

8 FDA 510(k) clearances · Product code

79 daysmedian time to decision
165 days90th percentile
8clearances measured

FDA profile

Official device name
Lactoferrin, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5570
Medical specialty
Immunology
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RecordFirmDate
LEUKO EZ VUE (K071712)Techlab Inc., Corporate Research Center2007-12-04
IBD-SCAN (K042071)Techlab, Inc.2004-10-20
IBD-QUIK CHEK (K030704)Techlab, Inc.2003-04-21
IBD-CHEK (K011396)Techlab, Inc.2001-06-18
LEUKO-TEST (K951101)Techlab, Inc.1995-04-24
LACTOFERRIN MICROASSAY SYSTEM (K934473)Touch Scientific, Inc.1993-12-03
LACTOCARD (K931901)Touch Scientific, Inc.1993-07-06
LACTOPLATE (K852737)Mackeen Consultants, Ltd.1985-10-25

Track DEG automatically

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