TOA MEDICAL ELECTRONICS CA-1000— 510(k) K942096

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K942096 for TOA MEDICAL ELECTRONICS CA-1000, Substantially Equivalent on 1995-03-24. Applicant: Sysmex Corp..

Clearance details

Applicant: Sysmex Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1994-04-14
Decision date: 1995-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, 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.