FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS— 510(k) K874607

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K874607 for FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS, Substantially Equivalent on 1988-01-27. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LKN
Advisory panel: Unknown
Date received: 1987-11-09
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 364

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.