Microscan (R) Microstrep Plus (R) Panels
FDA 510(k) K111205 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK111205
Submission
- Device name
- Microscan (R) Microstrep Plus (R) Panels
- Applicant
- Siemens Healthcare Diagnostics, Inc.
West Sacramento, CA, US - Received
- April 29, 2011
- Decision date
- July 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K110583 | Sensititre OptireadLRG · Traditional | Trek Diagnostic Systems, Ltd. | 09/22/2011SE |
| K103532 | Autoreader 2LRG · Traditional | Trek Diagnostic Systems | 08/26/2011SE |
| K111677 | Microscan(R) Microstrep Plus(R)LRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/04/2011SE |
| K101425 | Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesLRG · Traditional | Siemens Healthcare Diagnostics | 09/10/2010SE |
| K081013 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test Cefoxitin ScreenLRG · Traditional | Siemens Healthcare Diagnostics | 09/08/2008SE |
| K071316 | Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Streptomycin…LRG · Traditional | Dade Behring, Inc. | 08/20/2007SE |
| K063299 | Microscan Microstrep Plus Panel-ClarithromycinLRG · Traditional | Dade Behring, Inc. | 11/27/2006SE |
| K063102 | Microscan Microstrep Plus Panel Cefaclor (0.5 - 8 Mcg/Ml)LRG · Traditional | Dade Behring, Inc. | 11/09/2006SE |
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Questions and answers
When was Microscan (R) Microstrep Plus (R) Panels cleared by the FDA?
Microscan (R) Microstrep Plus (R) Panels (K111205) received a 510(k) decision of Substantially Equivalent on July 20, 2011, 82 days after the submission was received.
What is the product code of K111205?
The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.