HUMAN CHORIONIC GONADO.-BETA RIA KIT— 510(k) K781310
Substantially EquivalentDiagnostics Biochem Canada, Inc.
FDA 510(k) clearance K781310 for HUMAN CHORIONIC GONADO.-BETA RIA KIT, Substantially Equivalent on 1978-08-31. Applicant: Diagnostics Biochem Canada, Inc..
Clearance details
- Applicant
- Diagnostics Biochem Canada, Inc.
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.