Hemochron Signature Elite— 510(k) K193041
Substantially EquivalentAccriva Diagnostics, Inc.
FDA 510(k) clearance K193041 for Hemochron Signature Elite, Substantially Equivalent on 2019-11-22. Applicant: Accriva Diagnostics, Inc..
Clearance details
- Applicant
- Accriva Diagnostics, Inc.
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.