Cobas U 701 Microscopy Analyzer

Counter, Urine Particle

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas U 701 Microscopy Analyzer.

Pre-market Notification Details

Device IDK200811
510k NumberK200811
Device Name:Cobas U 701 Microscopy Analyzer
ClassificationCounter, Urine Particle
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46256
ContactTeresa Carrow
CorrespondentTeresa Carrow
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46256
Product CodeLKM  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-27
Decision Date2020-11-06

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