510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200308Substantially Equivalent

MTS Lefamulin 0.016- 256 µg/mL

Liofilchem S. R. 1., Roseto Degli Abruzzi, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K200308 is the FDA 510(k) clearance record for MTS Lefamulin 0.016- 256 µg/mL, a class II device, cleared for Liofilchem S. R. 1. on under FDA product code JWY (Manual Antimicrobial Susceptibility Test Systems). FDA records list one 510(k) clearance for Liofilchem S. R. 1. As of , FDA records show no recalls naming K200308.

Clearance record

Decision date
Received
(60 days to decision)
Product code
JWY Manual Antimicrobial Susceptibility Test Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Liofilchem S. R. 1. Via Scozia Zona Ind Le, Roseto Degli Abruzzi, IT
510(k) summary
Statement
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