Cleared Traditional

THROMBONOSTIKA F1.2

K911434 · Organon Teknika Corp. · Hematology
Oct 1991
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K911434 is an FDA 510(k) clearance for the THROMBONOSTIKA F1.2, a Prothrombin Fragment 1.2 (Class II — Special Controls, product code MIF), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 31, 1991, 212 days after receiving the submission on April 2, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K911434 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1991
Decision Date October 31, 1991
Days to Decision 212 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code MIF — Prothrombin Fragment 1.2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320