510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240032Unknown

APO-Easy Genotyping kit

Firalis S.A., Huningue, FR / Direct, Unknown
FDA source (opens on fda.gov)

DEN240032 is the FDA 510(k) clearance record for APO-Easy Genotyping kit, a class II device, cleared for Firalis SA on under FDA product code SFC (Neurologic Disease Risk Assessment Molecular Test). FDA's definition for product code SFC reads: "A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of...". FDA records list one 510(k) clearance for Firalis SA. As of , FDA records show no recalls naming DEN240032.

Clearance record

Decision date
Received
(356 days to decision)
Product code
SFC Neurologic Disease Risk Assessment Molecular Test
Regulation
21 CFR 866.5850
Device class
Class II
Review panel
Immunology
Applicant
Firalis SA 35 Rue Du Fort, Huningue, FR
Third party review
No

Clearances, product code SFC

Trailing 12 months

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

FDA records show no clearances under product code SFC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFC, 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