Panels › Immunology › Product code DBI · Class 2

Complement C4, Antigen, Antiserum, Control

Regulation 866.5240

0510(k)s in 12 months (34 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

Top companies in DBI

Company	510(k)s	Recalls
Abbott Laboratories	1	1
The Binding Site	2	0
Boehringer Mannheim Corp.	2	0
Crestat Diagnostics, Inc.	2	0
Dako Corp.	2	0
G.D. Searle and Co.	2	0
Instrumentation Laboratory CO	2	0
Kallestad Laboratories, Inc.	2	0
Technicon Instruments Corp.	2	0
Applications Lab	1	0

Date	Firm and product	Code	Linked 510(k)
Aug 27, 2020	Roche Diagnostics Operations, Inc. Tina-quant Complement C4 ver.2, Catalog 05991994190 Terminated	DBI	K012359
May 16, 2018	Abbott Laboratories, Inc C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. Th Terminated	DBI	K983356

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