Cleared Traditional

SIMPLATE PEDIATRIC

K911745 · Organon Teknika Corp. · Hematology
Aug 1991
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K911745 is an FDA 510(k) clearance for the SIMPLATE PEDIATRIC, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 9, 1991, 113 days after receiving the submission on April 18, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K911745 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1991
Decision Date August 09, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCA — Device, Bleeding Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6100