Cleared Traditional

THROMBONOSTIKA F1.2

K964934 · Organon Teknika Corp. · Hematology
Mar 1997
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K964934 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 March 18, 1997, 99 days after receiving the submission on December 9, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K964934 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1996
Decision Date March 18, 1997
Days to Decision 99 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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