DeviceClearance

K053335

Substantially Equivalent

PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

Applicant
Meridian Bioscience, Inc.
Product code
LYR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cincinnati, OH, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.