FDA.reportPublic FDA data

510(k) K802196

Device
GOAT ANTI-HUMAN COMPLEMENT C4
Applicant
PROTOS LABORATORIES
510(k) number
K802196
Product code
DBI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-09-10
Regulation
866.5240
Classification name
Complement C4, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100455SPAPLUS ANALYZERThe Binding Site2010-09-03
K012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.2001-11-29
K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.2001-06-25
K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.2000-03-27
K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-03-01
K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.1999-12-20
K993481K-ASSAY C4Kamiya Biomedical Co.1999-11-29
K983356C4Abbott Laboratories1998-11-04
K964300N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.1997-07-14
K964297N-ASSAY TIA C4 TEST KITCrestat Diagnostics, Inc.1997-07-14
K962582OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1996-10-18
K962198QUANTEX C4Instrumentation Laboratory CO1996-09-26
K920010IL TEST COMPLEMENT 4Instrumentation Laboratory CO1992-03-13
K911899RAICHEM SPIA C4 REAGENTReagents Applications, Inc.1991-05-09
K892129EZ COMPLEMENT C4Diamedix Corp.1989-04-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases