510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240041Substantially Equivalent

IVD CAPSULE PSP; abioSCOPE

Abionic SA, Epalinges, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240041 is the FDA 510(k) clearance record for IVD CAPSULE PSP; abioSCOPE, a class II device, cleared for Abionic SA on under FDA product code SCX (Immunoassay For Host Biomarkers Of Sepsis). FDA's definition for product code SCX reads: "A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens". FDA records list one 510(k) clearance for Abionic SA. As of , FDA records show no recalls naming K240041.

Clearance record

Decision date
Received
(264 days to decision)
Product code
SCX Immunoassay For Host Biomarkers Of Sepsis
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Abionic SA Rte. De La Corniche 5, Epalinges, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCX

Trailing 12 months

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

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