FDA 510(k) Applications Submitted by PATRICIA FRANKS

FDA 510(k) Number	Submission Date	Device Name	Applicant
K050053	01/10/2005	HEMORAM/AGGRAM ANALYZER	HELENA LABORATORIES
K100103	01/13/2010	SPECIALTY ASSAYED CONTROL-2	HELENA LABORATORIES
K020467	02/12/2002	SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452	HELENA LABORATORIES
K020625	02/26/2002	SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346	HELENA LABORATORIES
K020914	03/21/2002	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770	HELENA LABORATORIES
K061014	04/13/2006	ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP	HELENA LABORATORIES
K061069	04/17/2006	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458	HELENA LABORATORIES
K111369	05/16/2011	THE HELENA V8 IMMUNODISPLACEMENT KIT	HELENA LABORATORIES UK LTD
K061991	07/13/2006	PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA	HELENA LABORATORIES
K022333	07/18/2002	SPIFE LIPPOROTEIN-12, MODEL 3344	HELENA LABORATORIES
K022455	07/26/2002	SPIFE LD-12 KIT, MODEL 3338	HELENA LABORATORIES
K012723	08/15/2001	PLATELETWORKS	HELENA LABORATORIES
K022757	08/20/2002	SPIFE CK KIT, MODEL 3332, 3333	HELENA LABORATORIES
K013078	09/14/2001	ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752	HELENA LABORATORIES
K013466	10/18/2001	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343	HELENA LABORATORIES
K023761	11/08/2002	PLATELETWORKS, MODELS PW-A, PW-C	HELENA LABORATORIES