HANDHELD BASE UNIT— 510(k) K072920

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K072920 for HANDHELD BASE UNIT, Substantially Equivalent on 2008-01-31. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code GJS
Advisory panel: Hematology
Date received: 2007-10-15
Decision date: 2008-01-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.