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Panels › Hematology › Product code LCP · Class 2

Assay, Glycosylated Hemoglobin

Regulation 864.7470

0510(k)s in 12 months (249 all time)

1recalls in 12 months (103 all time)

98recalls that name a 510(k)

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Top companies in LCP

Company	510(k)s	Recalls
Heritage Labs International LLC	0	37
Bio-Rad Laboratories, Inc.	8	28
Helena Laboratories	19	0
Bio-Rad	15	0
Siemens Healthcare Diagnostics	3	12
Primus Corp.	9	0
Metrika, Inc.	7	1
Roche Diagnostics	5	3
Abbott Laboratories	7	0
Isolab, Inc.	7	0

Date	Firm and product	Code	Linked 510(k)
Mar 23, 2005	Roche Diagnostics Corp. Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. Terminated	LCP	K952337
Mar 23, 2005	Roche Diagnostics Corp. Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. Terminated	LCP	K952337
Mar 23, 2005	Roche Diagnostics Corp. Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. Terminated	LCP	K003120

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