COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Dna-reagents, Neisseria

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Amplicor Ct/ng Test For Neisseria Gonorrhoeae.

Pre-market Notification Details

Device IDK053289
510k NumberK053289
Device Name:COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ClassificationDna-reagents, Neisseria
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
ContactTheresa M Ambrose
CorrespondentTheresa M Ambrose
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46256
Product CodeLSL  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-25
Decision Date2006-08-10
Summary:summary

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