Thermo Scientific Sensititre ARIS HiQ System
FDA 510(k) K191914 · Thermo Fisher Scientific
510(k) numberK191914
Submission
- Device name
- Thermo Scientific Sensititre ARIS HiQ System
- Applicant
- Thermo Fisher Scientific
Oakwood Village, OH, US - Received
- July 17, 2019
- Decision date
- November 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code LRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191918 | Thermo Scientific Sensititre ARIS HiQ SystemLRG · Traditional | Thermo Fisher Scientific | 11/06/2019SE |
| 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 |
| K111205 | Microscan (R) Microstrep Plus (R) PanelsLRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/20/2011SE |
| 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 |
More from Dade Behring, Inc.
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| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 06/20/2025SE |
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| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 02/10/2025SE |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | 02/10/2025SE |
Questions and answers
When was Thermo Scientific Sensititre ARIS HiQ System cleared by the FDA?
Thermo Scientific Sensititre ARIS HiQ System (K191914) received a 510(k) decision of Substantially Equivalent on November 6, 2019, 112 days after the submission was received.
What is the product code of K191914?
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.