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Panels › Microbiology › Product code GWC · Class 1

Antisera, All Types, Streptococcus Pneumoniae

Regulation 866.3740

0510(k)s in 12 months (9 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

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Top companies in GWC

Company	510(k)s	Recalls
Armkel, LLC	3	0
American Micro Scan	1	0
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Lkb Instruments, Inc.	1	0
Pharmacia, Inc.	1	0
Ventrex Laboratories, Inc.	1	0
Wellcome Diagnostics	1	0

Decided	510(k)	Device and applicant	Code
Feb 7, 1989	K884966	BACTIGEN(R) S. PNEUMONIAE Armkel, LLC	GWC
Feb 7, 1989	K884965	BACTIGEN(R) MENINGITIDIS PANEL Armkel, LLC	GWC
Mar 25, 1987	K870029	IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE American Micro Scan	GWC
Dec 18, 1986	K862848	LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 Lkb Instruments, Inc.	GWC
Jul 2, 1984	K842239	VENTRESCREEN STREP A TEST Ventrex Laboratories, Inc.	GWC
May 2, 1984	K841376	WELLCOGEN S. PNEUMONIAE Wellcome Diagnostics	GWC
Sep 26, 1983	K831887	BACTIGEN S. PNEUMONIAE Armkel, LLC	GWC
Jul 30, 1982	K821960	BBL PNEUMOSLIDE TEST Bd Becton Dickinson Vacutainer Systems Preanalytic	GWC
Oct 31, 1980	K802337	PHADEBACT PNEUMOCOCCUS TEST Pharmacia, Inc.	GWC

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