Panels › Clinical Chemistry › Product code CDL · Class 2

Berthelot Indophenol, Urea Nitrogen

Regulation 862.1770

0510(k)s in 12 months (16 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in CDL

Company	510(k)s	Recalls
Sterling Diagnostics, Inc.	1	1
Volu Sol Medical Industries	2	0
Advanced Biomedical Methods, Inc.	1	0
Analytical & Research Chemicals, Inc.	1	0
Bio-Analytics Laboratories, Inc.	1	0
Biochemical Trade, Inc.	1	0
Data Medical Associates, Inc.	1	0
J. D. Assoc.	1	0
Reagents Applications, Inc.	1	0
Sclavo, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Dec 29, 2016	Sterling Diagnostics, Inc. Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated	CDL	K860154

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