510(k) K050585
- Device
- MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K050585
- Product code
- LRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-18
- Date received
- 2005-03-07
- Regulation
- 866.1640
- Classification name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT EUSEBIO
- Address
- 2040 Enterprise Blvd. West Sacramento CA US 95691 95691
FDA Registration Numbers#
- 1061932
- 1119779
- 3031977134
- 1530126
- 1924669
- 3003750284
- 1950204
- 8021914
- 3013718871
- 2919016
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRG #
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary