SIMPLATE PEDIATRIC— 510(k) K911745

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K911745 for SIMPLATE PEDIATRIC, Substantially Equivalent on 1991-08-09. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JCA
Advisory panel: Hematology
Date received: 1991-04-18
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.