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510(k) K200308

MTS Lefamulin 0.016- 256 µg/mL by Liofilchem S. R. 1. — Product Code JWY

K200308 is an FDA 510(k) premarket notification submitted by Liofilchem S. R. 1. for the device "MTS Lefamulin 0.016- 256 µg/mL". The FDA issued a decision of Substantially Equivalent on Apr 6, 2020. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 6, 2020
Date Received
Feb 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type
510(k)

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FDA data resources