FDA 510(k) Applications for Medical Device Product Code "LRG"
(Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K050585 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE | 03/18/2005 |
| K033948 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) | 03/01/2004 |
| K043545 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) | 02/17/2005 |
| K050043 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN | 03/29/2005 |
| K062179 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) | 08/23/2006 |
| K061872 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL | 08/23/2006 |
| K062276 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL | 08/23/2006 |
| K062927 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | 10/12/2006 |
| K062585 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | 09/19/2006 |
| K063102 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | 11/09/2006 |
| K063099 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | 11/01/2006 |
| K063101 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | 11/01/2006 |
| K063064 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | 10/26/2006 |
| K063053 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | 10/26/2006 |
| K062293 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) | 08/24/2006 |
| K062375 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | 10/26/2006 |
| K063065 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | 10/27/2006 |
| K062923 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | 10/13/2006 |
| K062290 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) | 09/01/2006 |
| K063299 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | 11/27/2006 |
| K071316 | DADE BEHRING, INC. | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN | 08/20/2007 |
| K041150 | DADE BEHRING, INC. | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS | 07/22/2004 |
| K062596 | DADE BEHRING, INC. | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | 09/19/2006 |
| K981199 | DADE MICROSCAN, INC. | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN | 11/18/1998 |
| K101425 | SIEMENS HEALTHCARE DIAGNOSTICS | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | 09/10/2010 |
| K081013 | SIEMENS HEALTHCARE DIAGNOSTICS | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN | 09/08/2008 |
| K111205 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | 07/20/2011 |
| K111677 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | MICROSCAN(R) MICROSTREP PLUS(R) | 08/04/2011 |
| K191914 | Thermo Fisher Scientific | Thermo Scientific Sensititre ARIS HiQ System | 11/06/2019 |
| K191918 | Thermo Fisher Scientific | Thermo Scientific Sensititre ARIS HiQ System | 11/06/2019 |
| K103532 | TREK DIAGNOSTIC SYSTEMS | AUTOREADER 2 | 08/26/2011 |
| K053243 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 01/20/2006 |
| K110583 | TREK DIAGNOSTIC SYSTEMS, LTD. | SENSITITRE OPTIREAD | 09/22/2011 |
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