QMS Plazomicin Immunoassay— 510(k) DEN180030

Unknown

Microgenics Corporation

FDA 510(k) clearance DEN180030 for QMS Plazomicin Immunoassay, Unknown on 2018-11-19. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant: Microgenics Corporation
Product code: Code QDR
Device class: Class 2
Regulation: 21 CFR 862.3460
Advisory panel: Clinical Toxicology
Date received: 2018-06-25
Decision date: 2018-11-19
Decision: Unknown
Clearance type: Direct
Location: Fremont, CA, US

View on FDA.gov ↗

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