510(k) K100455

Device: SPAPLUS ANALYZER
Applicant: THE BINDING SITE
510(k) number: K100455
Product code: DBI
Decision: Substantially Equivalent (SESE)
Decision date: 2010-09-03
Date received: 2010-02-17
Regulation: 866.5240
Classification name: Complement C4, Antigen, Antiserum, Control
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JAY GELLER
Address: 12100 Wilshire Blvd. Suite 500 Los Angeles CA US 90025 90025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05051700017602	Optilite C4 Kit	THE BINDING SITE GROUP LIMITED	2016-09-24
05051700015585	Human C4 Kit for use on SPAPLUS	THE BINDING SITE GROUP LIMITED	2016-09-24

Other 510(k) Records For Product Code DBI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K012359	TINA-QUANT COMPLEMENT C4 TEST SYSTEM	Roche Diagnostics Corp.	2001-11-29
K010325	WAKO AUTOKIT C4	Wako Chemicals USA, Inc.	2001-06-25
K000468	RANDOX COMPLEMENT C4	Randox Laboratories, Ltd.	2000-03-27
K994293	DIMENSION C4 FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2000-03-01
K981785	C4 MININEPH ANTISERUM	The Binding Site, Ltd.	1999-12-20
K993481	K-ASSAY C4	Kamiya Biomedical Co.	1999-11-29
K983356	C4	Abbott Laboratories	1998-11-04
K964300	N-ASSAY TIA MULTI V-NL	Crestat Diagnostics, Inc.	1997-07-14
K964297	N-ASSAY TIA C4 TEST KIT	Crestat Diagnostics, Inc.	1997-07-14
K962582	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	1996-10-18
K962198	QUANTEX C4	Instrumentation Laboratory CO	1996-09-26
K920010	IL TEST COMPLEMENT 4	Instrumentation Laboratory CO	1992-03-13
K911899	RAICHEM SPIA C4 REAGENT	Reagents Applications, Inc.	1991-05-09
K892129	EZ COMPLEMENT C4	Diamedix Corp.	1989-04-14
K890564	SPQ(TM) ANTIBODY REAGENT SET II FOR C4	Atlantic Antibodies	1989-02-17

Legacy Summary#

summary

FDA Review#

Decision Summary