HSV-2 ELISA IGG, MODEL EL0920G— 510(k) K993724

Substantially Equivalent

Mrl Diagnostics

FDA 510(k) clearance K993724 for HSV-2 ELISA IGG, MODEL EL0920G, Substantially Equivalent on 2000-02-01. Applicant: Mrl Diagnostics.

Clearance details

Applicant: Mrl Diagnostics
Product code: Code MYF
Advisory panel: Microbiology
Date received: 1999-11-03
Decision date: 2000-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

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.