510(k) K020128— ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2002-01-15
Decision date: 2002-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, 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.