HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50— 510(k) K152838

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K152838 for HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50, Substantially Equivalent on 2015-11-24. Applicant: Hardy Diagnostics. Device class: 2.

Clearance details

Applicant
Hardy Diagnostics
Product code
Code JTN
Device class
Class 2
Regulation
21 CFR 866.1620
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Maria, CA, US
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