510(k) K890131— TARGET(TM) QUANTITATIVE HCG

Substantially Equivalent

V-Tech, Inc.

Clearance details

Applicant
V-Tech, Inc.
Product code
Code JHI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Monte, 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.