INNOVACON HCG UKTRA TEST DEVICE— 510(k) K062361

Substantially Equivalent

Innovacon, Inc.

FDA 510(k) clearance K062361 for INNOVACON HCG UKTRA TEST DEVICE, Substantially Equivalent on 2006-10-23. Applicant: Innovacon, Inc..

Clearance details

Applicant: Innovacon, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2006-08-14
Decision date: 2006-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.