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LIE — Reagent/Device, Inoculum Calibration Class II

FDA Device Classification

Classification Details

Product Code
LIE
Device Class
Class II
Regulation Number
866.1640
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221493beckman coulterMicroScan Prompt Inoculation System-DApril 5, 2023
K103456trek diagnostic systemsTHE SENSITITRE AIMJune 22, 2011
K110331trek diagnostic systemsSENSITITRE AIM (TM)April 27, 2011
K935566radiometer americaSENSI-CAL AMCO AEPA-1March 29, 1994
K911059scientific device laboratoryTURBIDOMETRIC STANDARDJune 10, 1991
K890339difco laboratoriesDIFCO DIRECTOR INOCULATION SYSTEMFebruary 7, 1989
K8202993mPROMPT INOCULATION SYSTEMMarch 15, 1982