Elecsys HSV-1 IgG (08948844160)— 510(k) K220923

Name: FDA 510(k) clearance K220923
Creator: U.S. Food and Drug Administration
Published: 2022-10-12

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220923 for Elecsys HSV-1 IgG (08948844160), Substantially Equivalent on 2022-10-12. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MXJ
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2022-03-31
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23
K162276 — SeraQuest Herpes Type 1 Specific IgG2016-10-01
K143236 — Theranos Herpes Simplex Virus-1 IgG Assay2015-07-02
K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST2014-02-28

More clearances from Roche Diagnostics

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K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
K252323 — cobas pulse blood glucose monitoring system2026-06-12
K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260048 — Elecsys Anti-HAV IgM2026-04-07

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.