COAGUCHEK XS SYSTEM

Test, Time, Prothrombin

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Coaguchek Xs System.

Pre-market Notification Details

Device IDK062925
510k NumberK062925
Device Name:COAGUCHEK XS SYSTEM
ClassificationTest, Time, Prothrombin
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
ContactTheresa Bush
CorrespondentTheresa Bush
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-28
Decision Date2007-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00365702127104 K062925 000
00365702125100 K062925 000
04015630945689 K062925 000

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