TINA-QUANT APOLIPOPROTEIN B VER.2

Lipoprotein, Low-density, Antigen, Antiserum, Control

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Apolipoprotein B Ver.2.

Pre-market Notification Details

Device IDK013207
510k NumberK013207
Device Name:TINA-QUANT APOLIPOPROTEIN B VER.2
ClassificationLipoprotein, Low-density, Antigen, Antiserum, Control
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
ContactKay A Taylor
CorrespondentKay A Taylor
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
Product CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-25
Decision Date2001-11-13
Summary:summary

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