Panels › Clinical Chemistry › Product code CJW · Class 2

Bromcresol Purple Dye-Binding, Albumin

Regulation 862.1035

0510(k)s in 12 months (18 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in CJW

Company	510(k)s	Recalls
Abbott Laboratories	3	0
Em Diagnostic Systems, Inc.	2	0
A.P. Total Care, Inc.	1	0
Abbott Ireland Diagnostics Division	1	0
Abbott Mfg., Inc.	1	0
Biochemical Trade, Inc.	1	0
Boehringer Mannheim Corp.	1	0
Intersect Systems, Inc.	1	0
Quantimetrix Corp.	1	0
Randox Laboratories, Ltd.	1	0

Date	Firm and product	Code	Linked 510(k)
Mar 18, 2019	Roche Diagnostics Corporation Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems. Terminated	CJW	K844426

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