EMDS GLUCOSE TEST PACK ITEM 67656/95— 510(k) K855080

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K855080 for EMDS GLUCOSE TEST PACK ITEM 67656/95, Substantially Equivalent on 1986-02-11. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 1985-12-19
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.