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Panels › Immunology › Product code NQD · Class 2

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Regulation 866.5270

1510(k)s in 12 months (19 all time)

0recalls in 12 months (3 all time)

3recalls that name a 510(k)

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Top companies in NQD

Company	510(k)s	Recalls
Dade Behring, Inc.	5	0
Siemens Healthcare Diagnostics, Inc.	2	2
Roche Diagnostics	3	0
Beckman Coulter, Inc.	2	0
Olympus America, Inc.	2	0
Diagnostic Products Corporation	1	0
Ortho-Clinical Diagnostics, Inc.	1	0
Roche Diagnostics Operations, Inc.	0	1
SENTINEL CH. SpA	1	0
Siemens Healthcare Diagnostics Products GmbH	1	0

Date	Firm and product	Code	Linked 510(k)
Jan 24, 2017	Roche Diagnostics Operations, Inc. Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-re Terminated	NQD	K042485
Jan 7, 2016	Siemens Healthcare Diagnostics Inc Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067 Terminated	NQD	K060369
Jan 7, 2016	Siemens Healthcare Diagnostics Inc Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP SMN:10445066 Terminated	NQD	K062924

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