Cleared Traditional

K964934 - THROMBONOSTIKA F1.2

K964934 is an FDA 510(k) clearance for THROMBONOSTIKA F1.2, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code MIF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

K964934 is an FDA 510(k) clearance for the THROMBONOSTIKA F1.2. Classified as Prothrombin Fragment 1.2 (product code MIF), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K964934

510(k) Number K964934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 113d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIF Device Classification - Class 2, Special Controls

Product Code MIF Prothrombin Fragment 1.2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - MIF Prothrombin Fragment 1.2

Devices cleared under the same product code (MIF) and FDA review panel - the closest regulatory comparables to K964934.
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
K042687 · Dade Behring, Inc. · Dec 2004
TPP
K962176 · Panbio, Inc. · Oct 1996
ENZYGNOST F 1+2
K922934 · Behring Diagnostics, Inc. · Nov 1992
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA
K920895 · Baxter Diagnostics, Inc. · Jun 1992
THROMBONOSTIKA F1.2
K911434 · Organon Teknika Corp. · Oct 1991