Thermo Scientific Sensititre ARIS HiQ System— 510(k) K191918
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K191918 for Thermo Scientific Sensititre ARIS HiQ System, Substantially Equivalent on 2019-11-06. Applicant: Thermo Fisher Scientific. Device class: 2.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- Code LRG
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakwood Village, OH, US
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Recalls naming K191918
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191918.
Data sourced from openFDA. This site is unofficial and independent of the FDA.