PROFILE ONE OMNI— 510(k) K882559

Substantially Equivalent

Modular Diagnostic Systems, Inc.

FDA 510(k) clearance K882559 for PROFILE ONE OMNI, Substantially Equivalent on 1988-08-08. Applicant: Modular Diagnostic Systems, Inc..

Clearance details

Applicant: Modular Diagnostic Systems, Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1988-06-21
Decision date: 1988-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syracuse, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.