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

Name: FDA 510(k) clearance K143236
Creator: U.S. Food and Drug Administration
Published: 2015-07-02

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.. Device class: 2.

Clearance details

Applicant: Theranos, Inc.
Product code: Code MXJ
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2014-11-12
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXJ

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K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls2023-09-20
K220923 — Elecsys HSV-1 IgG (08948844160)2022-10-12
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23
K162276 — SeraQuest Herpes Type 1 Specific IgG2016-10-01
K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST2014-02-28

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.