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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid amplification test for the quantitation of bk virus (bk) dna
510(k) Number K202215
Device Name cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Applicant Contact rita hoady
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Correspondent Contact rita hoady
Regulation Number866.3183
Classification Product Code
QMI  
Date Received08/06/2020
Decision Date 09/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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