Panels › Clinical Chemistry › Product code JHY · Class 2

Colorimetric Method, Cpk Or Isoenzymes

Regulation 862.1215

0510(k)s in 12 months (40 all time)

0recalls in 12 months (2 all time)

1recalls that name a 510(k)

Top companies in JHY

Company	510(k)s	Recalls
Hybritech, Inc.	5	0
Roche Diagnostics	3	0
Abbott Laboratories	2	0
Intl. Immunoassay Laboratories, Inc.	2	0
Roche Diagnostic Systems, Inc.	2	0
Siemens Healthcare Diagnostics	1	1
American Research Products Co.	1	0
Amersham Corp.	1	0
Amresco, Inc.	1	0
Bayer Corp.	1	0

Date	Firm and product	Code	Linked 510(k)
May 4, 2018	Siemens Healthcare Diagnostics, Inc. Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge Terminated	JHY	K143720
Mar 11, 2011	BioCheck Inc CK-MB ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum. Terminated	JHY	None listed

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