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LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Class II

FDA Device Classification

Classification Details

Product Code
LHL
Device Class
Class II
Regulation Number
866.3300
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K984123zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM.January 11, 1999
K970149zeus scientificLEGIONELLA ELISA TEST SYSTEMJune 18, 1997
K963318armkelLEGIONELLA IGG/IGM ELISA TEST SYSTEMMarch 3, 1997
K921421pro-labLEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYJuly 28, 1992
K871328e.i. dupont de nemours and coDU PONT LEGIONELLA URINARY ANTIGEN - RIA KITSeptember 2, 1987
K864006medical diagnostic technologiesLEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TESTApril 20, 1987
K854108medical diagnostic technologiesPOLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIONovember 12, 1985
K852237genetic systemsLEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KITAugust 22, 1985
K842683genetic systemsGENETIC SYS LEGIONELLA IMMUNOFLURORESAugust 2, 1984
K832896biodan medical systemsLEGIONELLA INDIRECT FLUORESCENT ANTIBODOctober 14, 1983
K831760bionetic laboratory productsLEGIONELLA IFA KIT IAugust 8, 1983
K831026zeus technologiesINDIRECT FLUORESCENT ANTIBODY REAGENTSJune 22, 1983
K830820bionetic laboratory productsLEGIONELLA DFA KIT IJune 8, 1983
K822859zeus technologiesDIRECT FA CONJUGATE FOR LEGIONELLA SPPFebruary 16, 1983
K822066biodan medical systemsLEGIONELLA PNEUMOPHILASeptember 21, 1982
K813339springwood microbiologicalsDIRECT FA CONJUGATE FOR LEGIONELLA SPDecember 18, 1981
K812007centers for disease control and preventionLEGIONELLA INDIRECT FLUOR. ANTIBODYSeptember 8, 1981
K812006centers for disease control and preventionLEGIONELLA DIRECT FLUORESCENT ANTIBODYSeptember 8, 1981