Atlas FDA

LHL

18 FDA 510(k) clearances · Product code

84 daysmedian time to decision
187 days90th percentile
18clearances measured

FDA profile

Official device name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3300
Medical specialty
Microbiology
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RecordFirmDate
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E (K984123)Zeus Scientific, Inc.1999-01-11
LEGIONELLA ELISA TEST SYSTEM (K970149)Zeus Scientific, Inc.1997-06-18
LEGIONELLA IGG/IGM ELISA TEST SYSTEM (K963318)Armkel, LLC1997-03-03
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (K921421)Pro-Lab, Inc.1992-07-28
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT (K871328)E.I. Dupont DE Nemours & Co., Inc.1987-09-02
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST (K864006)Medical Diagnostic Technologies, Inc.1987-04-20
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO (K854108)Medical Diagnostic Technologies, Inc.1985-11-12
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (K852237)Genetic Systems Corp.1985-08-22
GENETIC SYS LEGIONELLA IMMUNOFLURORES (K842683)Genetic Systems Corp.1984-08-02
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD (K832896)Biodan Medical Systems, Ltd.1983-10-14
LEGIONELLA IFA KIT I (K831760)Bionetic Laboratory Products1983-08-08
INDIRECT FLUORESCENT ANTIBODY REAGENTS (K831026)Zeus Technologies1983-06-22
LEGIONELLA DFA KIT I (K830820)Bionetic Laboratory Products1983-06-08
DIRECT FA CONJUGATE FOR LEGIONELLA SPP (K822859)Zeus Technologies1983-02-16
LEGIONELLA PNEUMOPHILA (K822066)Biodan Medical Systems, Ltd.1982-09-21
DIRECT FA CONJUGATE FOR LEGIONELLA SP (K813339)Springwood Microbiologicals1981-12-18
LEGIONELLA INDIRECT FLUOR. ANTIBODY (K812007)Centers for Disease Control and Prevention1981-09-08
LEGIONELLA DIRECT FLUORESCENT ANTIBODY (K812006)Centers for Disease Control and Prevention1981-09-08

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