Name: Predicase
Price: 199 USD

K-number	K252114
Device name	MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
Applicant	Liofilchem s.r.l.
Product code	JWY
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	866.1640

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Everything you need for a 510(k) submission. Nothing you don't.