LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class II
FDA product code LRG covers "Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K191918 | thermo fisher scientific | Thermo Scientific Sensititre ARIS HiQ System | November 6, 2019 |
| K191914 | 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 |
| K063101 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | November 1, 2006 |
| K063099 | dade behring | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | November 1, 2006 |
| K063065 | dade behring | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | October 27, 2006 |
| K062375 | dade behring | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | October 26, 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 |
| 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 |