FDA 510(k) Applications Submitted by Shannon Popson

FDA 510(k) Number Submission Date Device Name Applicant
K111205 04/29/2011 MICROSCAN (R) MICROSTREP PLUS (R) PANELS SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K091264 04/30/2009 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 SIEMENS HEALTHCARE DIAGNOSTICS
K111394 05/18/2011 MICROSCAN MICROSTEP Siemens Healthcare Diagnostics Inc.
K091949 07/01/2009 MICROSCAN MICROSTREP PLUS, MODEL B1027-201 SIEMENS HEALTHCARE DIAGNOSTICS
K172255 07/26/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Beckman Coulter, Inc
K062179 07/31/2006 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) DADE BEHRING, INC.
K062290 08/07/2006 MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) DADE BEHRING, INC.
K152346 08/20/2015 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) BECKMAN COULTER, INC.
K062585 09/01/2006 MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN DADE BEHRING, INC.
K062596 09/01/2006 MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID DADE BEHRING, INC.
K092919 09/23/2009 MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 SIEMENS HEALTHCARE DIAGNOSTICS
K172912 09/25/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) Beckman Coulter Inc.
K162740 09/30/2016 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) BECKMAN COULTER, INC.
K063053 10/04/2006 MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) DADE BEHRING, INC.
K063102 10/10/2006 MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) DADE BEHRING, INC.


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