510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002139Substantially Equivalent

Etest Linezolid

Ab Biodisk, Solna, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002139 is the FDA 510(k) clearance record for ETEST LINEZOLID, a class II device, cleared for Ab Biodisk on under FDA product code LTX (Discs, Elution). FDA records list 64 510(k) clearances for Ab Biodisk, from to . As of , FDA records show no recalls naming K002139.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LTX Discs, Elution
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Ab Biodisk Dalvagen 10, Solna, SE
510(k) summary
Statement
Third party review
No

Clearances, product code LTX

Trailing 12 months

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

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