PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST— 510(k) K984343

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K984343 for PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST, Substantially Equivalent on 1999-06-25. Applicant: Meridian Diagnostics, Inc..

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 1998-12-04
Decision date: 1999-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.