FDA 510(k) Applications Submitted by ASA KARLSSON

FDA 510(k) Number Submission Date Device Name Applicant
K180936 04/10/2018 ETEST Telavancin (TLA) (0.002-32 ug/mL) bioMerieux SA
K181092 04/25/2018 CHROMID CARBA agar (CARB) bioMerieux SA
K162385 08/25/2016 RAPIDEC CARBA NP BIOMERIEUX SA
K102535 09/03/2010 ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML BIOMERIEUX SA
K102668 09/16/2010 ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML BIOMERIEUX
K093604 11/20/2009 ETEST MOXIFLOXACIN 0.002-32 UG/ML AB BIOMERIEUX


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