K870133
Substantially EquivalentHY 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
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.