MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100— 510(k) K924259

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K924259 for MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100, Substantially Equivalent on 1992-11-25. Applicant: Medix Biotech, Inc..

Clearance details

Applicant
Medix Biotech, Inc.
Product code
Code JHI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Foster City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse 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.