COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

Hexokinase, Glucose

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Glucose Hk Gen. 3 Test System.

Pre-market Notification Details

Device IDK061048
510k NumberK061048
Device Name:COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
ClassificationHexokinase, Glucose
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactCorina Harper
CorrespondentCorina Harper
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-17
Decision Date2006-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04015630925025 K061048 000
04015630920297 K061048 000

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