510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260447Substantially Equivalent

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

bioMerieux, Inc., Marcy-L'Etoile, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260447 is the FDA 510(k) clearance record for ETEST Gepotidacin (GEP) (0.016-256 µg/mL), a class II device, cleared for bioMérieux SA on under FDA product code JWY (Manual Antimicrobial Susceptibility Test Systems). FDA records list 408 510(k) clearances for bioMérieux SA, from to . As of , FDA records show no recalls naming K260447.

Clearance record

Decision date
Received
(69 days to decision)
Product code
JWY Manual Antimicrobial Susceptibility Test Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
bioMérieux SA 376 Chemin De L'Orme, Marcy-L'Etoile, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWY

Trailing 12 months
2 clearances under product code JWY in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260