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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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