Theranos Herpes Simplex Virus-1 IgG Assay— 510(k) K143236

Substantially Equivalent

Theranos, Inc.

FDA 510(k) clearance K143236 for Theranos Herpes Simplex Virus-1 IgG Assay, Substantially Equivalent on 2015-07-02. Applicant: Theranos, Inc..

Clearance details

Applicant: Theranos, Inc.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 2014-11-12
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, 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.