Atlas FDA

Thermo Scientific Sensititre ARIS HiQ System

FDA 510(k) clearance K191918 · decided 2019-11-06

Clearance details

K-number
K191918
Device name
Thermo Scientific Sensititre ARIS HiQ System
Applicant
Thermo Fisher Scientific
Decision
Substantially Equivalent
Date received
2019-07-18
Decision date
2019-11-06
Days to decision
111 days
Clearance type
Traditional
Product code
LRG
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Oakwood Village, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold a recall (Z-1395-2025)Remel, Inc2025-03-19