FDA 510(k) Applications for Medical Device Product Code: GFO (Activated Partial Thromboplastin)

FDA 510(k) Applications for Medical Device Product Code "GFO"
(Activated Partial Thromboplastin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K961892	ANALYTICAL CONTROL SYSTEMS, INC.	SPECKTIN-LA TEST SET	03/07/1997
K955450	BEHRING DIAGNOSTICS, INC.	PATHROMTIN SL	04/19/1996
K014028	CARESIDE HEMOTOLOGY, INC.	CARESIDE APTT	02/08/2002
K053111	DIAGNOSTICA STAGO, INC.	STA-CEPHASCREEN KIT	05/04/2006
K050221	INSTRUMENTATION LABORATORY CO.	HEMOSIL SILICA CLOTTING TIME	03/30/2005
K160445	INSTRUMENTATION LABORATORY CO.	HemosIL Silica Clotting Time	03/16/2016
K060688	INSTRUMENTATION LABORATORY CO.	HEMOSIL SYNTHASIL	04/13/2006
K973306	INSTRUMENTATION LABORATORY CO.	IL TEST APTT-SP	11/04/1997
K972831	INTERNATIONAL TECHNIDYNE CORP.	HEMOCHRON CITRATE APTT	11/20/1997
K014008	ITC, INC.	HEMOCHRON JR. CITRATE APTT CUVETTE	01/24/2002
K955638	ORTHO DIAGNOSTIC SYSTEMS, INC.	SYNTHAFAX APTT REAGENT	04/23/1996
K193556	Precision BioLogic	Cryocheck Hex LA	10/23/2020
K992711	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094	12/06/1999
K992712	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334	12/06/1999
K022021	VITAL SCIENTIFIC N.V.	VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT	11/01/2002