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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 Drive
pleasanton,  CA  94588 -2722
Applicant Contact raji grewal
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
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
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