TAS ANALYZER, MODEL 1009— 510(k) K990566

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K990566 for TAS ANALYZER, MODEL 1009, Substantially Equivalent on 1999-05-14. Applicant: Cardiovascular Diagnostics, Inc..

Clearance details

Applicant: Cardiovascular Diagnostics, Inc.
Product code: 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

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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.