Product code LRG
- Device name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | 2019-11-06 |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | 2019-11-06 |
| K110583 | SENSITITRE OPTIREAD | Trek Diagnostic Systems, Ltd. | 2011-09-22 |
| K103532 | AUTOREADER 2 | Trek Diagnostic Systems | 2011-08-26 |
| K111677 | MICROSCAN(R) MICROSTREP PLUS(R) | Siemens Healthcare Diagnostics, Inc. | 2011-08-04 |
| K111205 | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | Siemens Healthcare Diagnostics, Inc. | 2011-07-20 |
| K101425 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | Siemens Healthcare Diagnostics | 2010-09-10 |
| K081013 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN | Siemens Healthcare Diagnostics | 2008-09-08 |
| K071316 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN | Dade Behring, Inc. | 2007-08-20 |
| K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | Dade Behring, Inc. | 2006-11-27 |
| K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | Dade Behring, Inc. | 2006-11-09 |
| K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | Dade Behring, Inc. | 2006-11-01 |
| K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | Dade Behring, Inc. | 2006-11-01 |
| K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | Dade Behring, Inc. | 2006-10-27 |
| K062375 | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | Dade Behring, Inc. | 2006-10-26 |
| K063053 | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | Dade Behring, Inc. | 2006-10-26 |
| K063064 | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | Dade Behring, Inc. | 2006-10-26 |
| K062923 | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | Dade Behring, Inc. | 2006-10-13 |
| K062927 | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | Dade Behring, Inc. | 2006-10-12 |
| K062585 | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | Dade Behring, Inc. | 2006-09-19 |
| K062596 | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | Dade Behring, Inc. | 2006-09-19 |
| K062290 | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) | Dade Behring, Inc. | 2006-09-01 |
| K062293 | MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) | Dade Behring, Inc. | 2006-08-24 |
| K061872 | MICROSCAN MICROSTREP PLUS PANEL | Dade Behring, Inc. | 2006-08-23 |
| K062276 | MICROSCAN MICROSTREP PLUS PANEL | Dade Behring, Inc. | 2006-08-23 |
| K062179 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) | Dade Behring, Inc. | 2006-08-23 |
| K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2006-01-20 |
| K050043 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN | Dade Behring, Inc. | 2005-03-29 |
| K050585 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE | Dade Behring, Inc. | 2005-03-18 |
| K043545 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) | Dade Behring, Inc. | 2005-02-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590657383 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657680 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657673 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657659 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657642 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657635 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657574 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657567 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657550 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657536 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657529 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657512 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657499 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657475 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657406 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657376 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657543 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657932 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657925 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657918 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657901 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657895 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657888 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657871 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657864 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657857 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657840 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657826 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657819 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657796 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |