K990566

Substantially Equivalent

TAS ANALYZER, MODEL 1009

Applicant: Cardiovascular Diagnostics, Inc.
Product code: JPA
Advisory panel: Hematology
Date received: 1999-02-22
Decision date: 1999-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.