Panels › Clinical Chemistry › Product code JJS · Class 1

Controls For Blood-Gases, (Assayed And Unassayed)

Regulation 862.1660

0510(k)s in 12 months (67 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in JJS

Company	510(k)s	Recalls
Radiometer America, Inc.	9	1
Bio-Rad	9	0
Bionostics, Inc.	5	0
Phoenix Diagnostics, Inc.	5	0
American Dade	3	0
Analytical Products, Inc.	3	0
Corning Medical & Scientific	3	0
Instrumentation Laboratory CO	3	0
Radiometer Medical Aps	3	0
Ciba Corning Diagnostics Corp.	2	0

Date	Firm and product	Code	Linked 510(k)
Sep 7, 2017	Radiometer America Inc AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas anal Terminated	JJS	K980135

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