LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class II
FDA Device Classification
Classification Details
- Product Code
- LRG
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K191914 | thermo fisher scientific | Thermo Scientific Sensititre ARIS HiQ System | November 6, 2019 |
| K191918 | thermo fisher scientific | Thermo Scientific Sensititre ARIS HiQ System | November 6, 2019 |
| K110583 | trek diagnostic systems | SENSITITRE OPTIREAD | September 22, 2011 |
| K103532 | trek diagnostic systems | AUTOREADER 2 | August 26, 2011 |
| K111677 | siemens healthcare diagnostics | MICROSCAN(R) MICROSTREP PLUS(R) | August 4, 2011 |
| K111205 | siemens healthcare diagnostics | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | July 20, 2011 |
| K101425 | siemens healthcare diagnostics | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | September 10, 2010 |
| K081013 | siemens healthcare diagnostics | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN | September 8, 2008 |
| K071316 | dade behring | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPT | August 20, 2007 |
| K063299 | dade behring | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | November 27, 2006 |
| K063102 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | November 9, 2006 |
| K063099 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | November 1, 2006 |
| K063101 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | November 1, 2006 |
| K063065 | dade behring | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | October 27, 2006 |
| K063064 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | October 26, 2006 |
| K063053 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | October 26, 2006 |
| K062375 | dade behring | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | October 26, 2006 |
| K062923 | dade behring | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | October 13, 2006 |
| K062927 | dade behring | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | October 12, 2006 |
| K062585 | dade behring | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | September 19, 2006 |