Cleared Traditional

K912876 - FIBRINOSTIKA FBDP MICROELISA SYSTEM

K912876 is an FDA 510(k) clearance for FIBRINOSTIKA FBDP MICROELISA SYSTEM, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K912876 · Organon Teknika Corp. · Hematology device
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Oct 1991
Decision
100d
Days
Class 2
Risk

K912876 is an FDA 510(k) clearance for the FIBRINOSTIKA FBDP MICROELISA SYSTEM. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 100 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 - K912876

510(k) Number K912876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date October 09, 1991
Days to Decision 100 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
13d faster than avg
Panel avg: 113d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAP Device Classification - Class 2, Special Controls

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 44
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K912876.
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698 · Organon Teknika Corp. · Aug 1992
FDP PLASMA TEST KIT
K920943 · American Bioproducts Co. · Jul 1992
D-DIMER WELLCOTEST (HA10)
K915203 · Wellcome Diagnostics · Jan 1992
DATA-FI DIMERTEST LATEX ASSAY
K872195 · American Dade · Aug 1987
ASSERACHROM D-DI KIT
K862156 · American Bioproducts Co. · Sep 1986