510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080017Substantially Equivalent

Vidas Afp Assay

bioMerieux, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080017 is the FDA 510(k) clearance record for VIDAS AFP ASSAY, a class II device, cleared for bioMerieux, Inc. on under FDA product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K080017.

Clearance record

Decision date
Received
(267 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
bioMerieux, Inc. 595 Anglum Rd., Hazelwood MO
510(k) summary
Summary PDF
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