LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | LRG |
|---|---|
| Device Name | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | Nov 6, 2019 | SESE |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | Nov 6, 2019 | SESE |
| K110583 | SENSITITRE OPTIREAD | Trek Diagnostic Systems, Ltd. | Sep 22, 2011 | SESE |
| K103532 | AUTOREADER 2 | Trek Diagnostic Systems | Aug 26, 2011 | SESE |
| K111677 | MICROSCAN(R) MICROSTREP PLUS(R) | Siemens Healthcare Diagnostics, Inc. | Aug 4, 2011 | SESE |
| K111205 | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | Siemens Healthcare Diagnostics, Inc. | Jul 20, 2011 | SESE |
| K101425 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | Siemens Healthcare Diagnostics | Sep 10, 2010 | SESE |
| K081013 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN | Siemens Healthcare Diagnostics | Sep 8, 2008 | SESE |
| K071316 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN | Dade Behring, Inc. | Aug 20, 2007 | SESE |
| K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | Dade Behring, Inc. | Nov 27, 2006 | SESE |
| K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | Dade Behring, Inc. | Nov 9, 2006 | SESE |
| K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | Dade Behring, Inc. | Nov 1, 2006 | SESE |
| K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | Dade Behring, Inc. | Nov 1, 2006 | SESE |
| K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | Dade Behring, Inc. | Oct 27, 2006 | SESE |
| K063064 | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | Dade Behring, Inc. | Oct 26, 2006 | SESE |
| K063053 | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | Dade Behring, Inc. | Oct 26, 2006 | SESE |
| K062375 | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | Dade Behring, Inc. | Oct 26, 2006 | SESE |
| K062923 | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | Dade Behring, Inc. | Oct 13, 2006 | SESE |
| K062927 | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | Dade Behring, Inc. | Oct 12, 2006 | SESE |
| K062596 | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | Dade Behring, Inc. | Sep 19, 2006 | SESE |
Top Applicants
- Dade Behring, Inc. — 23 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Thermo Fisher Scientific — 2 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Siemens Healthcare Diagnostics — 2 clearances
