510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081709Substantially Equivalent

Olympus Afp - Alpha-Fetoprotein

Olympus Life Science Research Europa GmbH (Europa), O'Callaghans Mills, Co. Clare, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081709 is the FDA 510(k) clearance record for OLYMPUS AFP - ALPHA-FETOPROTEIN, a class II device, cleared for Olympus Life Science Research Europa GmbH (Europa) on under FDA product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer). FDA records list 3 510(k) clearances for Olympus Life Science Research Europa GmbH (Europa), from to . As of , FDA records show no recalls naming K081709.

Clearance record

Decision date
Received
(272 days to decision)
Product code
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Olympus Life Science Research Europa GmbH (Europa) Lismeehan, O'Callaghans Mills, Co. Clare, IE
510(k) summary
Statement
Third party review
No

Clearances, product code LOJ

Trailing 12 months

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

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