MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011— 510(k) K914696

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K914696 for MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011, Substantially Equivalent on 1991-11-13. Applicant: Medix Biotech, Inc..

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1991-10-18
Decision date: 1991-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.