510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191918Substantially Equivalent

Thermo Scientific Sensititre ARIS HiQ System

Thermo Fisher Scientific Oy, Oakwood Village OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191918 is the FDA 510(k) clearance record for Thermo Scientific Sensititre ARIS HiQ System, a class II device, cleared for Thermo Fisher Scientific on under FDA product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems). FDA records list 65 510(k) clearances for Thermo Fisher Scientific, from to . As of , FDA records show one recall naming K191918.

Clearance record

Decision date
Received
(111 days to decision)
Product code
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Thermo Fisher Scientific 1 Thermo Fisher Way, Oakwood Village OH
510(k) summary
Statement
Third party review
No

Clearances, product code LRG

Trailing 12 months

FDA records hold no clearances under product code LRG in the trailing twelve months.

FDA records show no clearances under product code LRG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260