Aztreonam Antimicrobial Susceptibility Test Disc

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K964490 ↗

FDA Product Code

JTN

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

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See all devices from Unipath, Ltd. →