HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)— 510(k) K172621

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K172621 for HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30), Substantially Equivalent on 2017-10-03. Applicant: Hardy Diagnostics.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTN
Advisory panel: Microbiology
Date received: 2017-08-31
Decision date: 2017-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

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