PACKETS FOR THE PREP OF DIALYSATES &— 510(k) K842154

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K842154 for PACKETS FOR THE PREP OF DIALYSATES &, Substantially Equivalent on 1984-07-31. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1984-05-30
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.