510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913467Substantially Equivalent

Toxogen

Biokit USA, Inc., Barcelona, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913467 is the FDA 510(k) clearance record for TOXOGEN, a class II device, cleared for Biokit USA, Inc. on under FDA product code LLA (Direct Agglutination Test, Toxoplasma Gondii). FDA records list 16 510(k) clearances for Biokit USA, Inc., from to . As of , FDA records show no recalls naming K913467.

Clearance record

Decision date
Received
(525 days to decision)
Product code
LLA Direct Agglutination Test, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Biokit USA, Inc. Can Male Llissa D'Amunt, Barcelona, ES
510(k) summary
Statement
Third party review
No

Clearances, product code LLA

Trailing 12 months

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

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