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510(k) K202215

Device
Cobas BKV, Cobas EBV/BKV Control Kit, Cobas Buffer Negative Control Kit
Applicant
Roche Molecular Systems, Inc.
510(k) number
K202215
Product code
QMI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-02
Date received
2020-08-06
Regulation
866.3183
Classification name
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rita Hoady
Address
4300 Hacienda Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QMI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241921Alinity m BKVAbbott Molecular, Inc.2025-03-24

Legacy Summary#

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FDA Review#

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