DeviceClearance

K160512

Substantially Equivalent

HardyCHROM ESBL

Applicant
Hardy Diagnostics
Product code
JSO
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Maria, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JSO

product code JSO
Malfunction
602
Total
602

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.