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LTT — Panels, Test, Susceptibility, Antimicrobial Class II

FDA Device Classification

Classification Details

Product Code
LTT
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
K243804beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mAugust 20, 2025
K250036beckman coulterMicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µgAugust 15, 2025
K250084beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mJuly 18, 2025
K202343beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µgNovember 16, 2020
K201423beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µgJune 29, 2020
K193536beckman coulterMicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - March 18, 2020
K193358beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16March 3, 2020
K183127beckman coulterMicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/February 12, 2019
K172337beckman coulterMicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/December 15, 2017
K172912beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µDecember 7, 2017
K172255beckman coulterMicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25December 1, 2017
K162740beckman coulterMicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)March 21, 2017
K150039siemens healthcare diagnosticsMicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)July 2, 2015
K131275siemens helathcare diagnosticsMICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELSNovember 8, 2013
K123933siemens healthcare diagnosticsMICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINEMarch 14, 2013
K111394siemens healthcare diagnosticsMICROSCAN MICROSTEPJune 22, 2011
K091949siemens healthcare diagnosticsMICROSCAN MICROSTREP PLUS, MODEL B1027-201January 26, 2010
K091264siemens healthcare diagnosticsMICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017July 22, 2009
K083262siemens healthcare diagnosticsMICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/February 18, 2009
K062773dade behringMICROSCAN MICROSTREP PLUS PANEL, PENICILLINOctober 13, 2006