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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 Dr.
Pleasanton,  CA  94588 -2722
Applicant Contact Rita Hoady
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
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
Predetermined Change
Control Plan Authorized		 No
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