MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011— 510(k) K914696
Substantially EquivalentMedix 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.. Device class: 2.
Clearance details
- Applicant
- Medix Biotech, Inc.
- Product code
- Code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
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More clearances from Medix Biotech, Inc.
view allAdverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . 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.