FDA 510(k) Applications for Medical Device Product Code: GTZ (Antisera, All Groups, Streptococcus Spp.)

FDA 510(k) Applications for Medical Device Product Code "GTZ"
(Antisera, All Groups, Streptococcus Spp.)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K952819	ABBOTT LABORATORIES	ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)	01/26/1996
K971522	ABBOTT LABORATORIES	ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II	03/03/1998
K012521	BINAX, INC.	BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST	11/30/2001
K991726	BINAX, INC.	BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI	08/27/1999
K960712	BINAX, INC.	BINAX STREP A TEST	03/22/1996
K010523	BINAX, INC.	MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST	03/15/2001
K962060	BIOSTAR, INC.	STREP A OIA MAX	07/23/1997
K962146	EXCEL SCIENTIFIC, INC.	EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT	10/07/1996
K955108	QUIDEL CORP.	CARDS Q.S. STREP A	04/15/1996
K011709	TRINITY BIOTECH, PLC	UNI-GOLD STREP A TEST KIT	11/08/2001
K962296	UNIPATH LTD.	STREPTOLEX-STAT	12/16/1996
K961423	WYNTEK DIAGNOSTICS, INC.	OSOM STREP A TEST	10/11/1996