HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G— 510(k) K062543

Substantially Equivalent

Focus Diagnostics, Inc.

FDA 510(k) clearance K062543 for HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G, Substantially Equivalent on 2007-02-01. Applicant: Focus Diagnostics, Inc..

Clearance details

Applicant: Focus Diagnostics, Inc.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 2006-08-30
Decision date: 2007-02-01
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.