Panels › Immunology › Product code DEH · Class 2

Lambda, Antigen, Antiserum, Control

Regulation 866.5550

0510(k)s in 12 months (53 all time)

0recalls in 12 months (4 all time)

4recalls that name a 510(k)

Top companies in DEH

Company	510(k)s	Recalls
Ventana Medical Systems, Inc.	17	0
Dako Corp.	9	0
The Binding Site, Ltd.	7	0
The Binding Site Group , Ltd.	1	4
Biotek Solutions, Inc.	4	0
Kallestad Laboratories, Inc.	4	0
Gelco Diagnostics, Inc.	2	0
Icl Scientific	2	0
Bartels Immunodiagnostic Supplies, Inc.	1	0
Beckman Instruments, Inc.	1	0

Decided	510(k)	Device and applicant	Code
Jul 27, 1978	K781220	ANTI-HUMAN LAMBDA SERUM Icl Scientific	DEH
Jul 27, 1978	K781025	LAMBDA SERUM (FREE) ANTI-HUMAN Icl Scientific	DEH
Oct 7, 1977	K771768	GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM G.D. Searle and Co.	DEH

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