HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950— 510(k) K071510

Substantially Equivalent

Focus Diagnostics, Inc.

FDA 510(k) clearance K071510 for HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950, Substantially Equivalent on 2007-09-24. Applicant: Focus Diagnostics, Inc..

Clearance details

Applicant: Focus Diagnostics, Inc.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 2007-06-04
Decision date: 2007-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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Adverse events under product code MXJ

product code MXJ

Injury: 139
Total: 139

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.