DeviceClearance

K193041

Substantially Equivalent

Hemochron Signature Elite

Applicant
Accriva Diagnostics, Inc.
Product code
JPA
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

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.