K870133

Substantially Equivalent

HY PBC FLASK

Applicant
Hy Laboratories, Ltd.
Product code
JSG
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rehovot 76326, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code JSG

product code JSG
Malfunction
817
Total
817

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.