ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls— 510(k) K213987

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K213987 for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls, Substantially Equivalent on 2023-09-20. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 2021-12-20
Decision date: 2023-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà D´Amunt, ES

Download summary PDF View on FDA.gov ↗

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.