ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

Bromcresol Green Dye-binding, Albumin

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Cobas Integra Albumin Gen. 2.

Pre-market Notification Details

Device IDK033009
510k NumberK033009
Device Name:ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
ClassificationBromcresol Green Dye-binding, Albumin
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactSherri L Coenen
CorrespondentSherri L Coenen
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-26
Decision Date2003-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336120958 K033009 000
07613336120941 K033009 000
04015630911509 K033009 000
04015630924820 K033009 000
04015630922581 K033009 000
04015630918898 K033009 000
04015630911523 K033009 000
04015630911516 K033009 000

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