EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95— 510(k) K861055

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K861055 for EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95, Substantially Equivalent on 1986-04-24. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1986-03-19
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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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.