HERPESELECT 1 ELISA IGG, MODEL EL0910G— 510(k) K021429

Name: FDA 510(k) clearance K021429
Creator: U.S. Food and Drug Administration
Published: 2002-07-29

Substantially Equivalent

Focus Technologies, Inc.

FDA 510(k) clearance K021429 for HERPESELECT 1 ELISA IGG, MODEL EL0910G, Substantially Equivalent on 2002-07-29. Applicant: Focus Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Focus Technologies, Inc.
Product code: Code MXJ
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2002-05-03
Decision date: 2002-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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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.