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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 Epstein-Barr Virus (Ebv) Dna
510(k) Number K203220
Device Name cobas BKV
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact Raji Grewal
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact Raji Grewal
Regulation Number866.3183
Classification Product Code
QLX  
Date Received11/02/2020
Decision Date 01/29/2021
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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