510(k) K031445— MAINLINE MAXIE HCG URINE PREGNANCY TEST

Substantially Equivalent

Mainline Technology, Inc.

Clearance details

Applicant: Mainline Technology, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2003-05-07
Decision date: 2003-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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.