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Panels › Immunology › Product code DCF · Class 2

Albumin, Antigen, Antiserum, Control

Regulation 866.5040

0510(k)s in 12 months (37 all time)

0recalls in 12 months (3 all time)

2recalls that name a 510(k)

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Top companies in DCF

Company	510(k)s	Recalls
Kallestad Diag, A Div. of Erbamont, Inc.	4	0
The Binding Site Group , Ltd.	3	0
Beckman Coulter, Inc.	1	1
Beckman Instruments, Inc.	2	0
Behring Diagnostics, Inc.	2	0
Dade Behring, Inc.	2	0
Ortho-Clinical Diagnostics, Inc.	1	1
Roche Diagnostics	2	0
Technicon Instruments Corp.	2	0
Unipath , Ltd.	2	0

Date	Firm and product	Code	Linked 510(k)
Oct 14, 2019	Ortho Clinical Diagnostics Inc 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry S Terminated	DCF	None listed
Apr 24, 2017	Beckman Coulter Inc. Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitat Terminated	DCF	K082251
Jul 30, 2013	Wako Life Sciences, Inc. uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 T Terminated	DCF	K100464

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