Cobas BKV

Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Bkv.

Pre-market Notification Details

Device IDK203220
510k NumberK203220
Device Name:Cobas BKV
ClassificationNucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactRaji Grewal
CorrespondentRaji Grewal
Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
Product CodeQLX  
CFR Regulation Number866.3183 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-01-29

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