cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit— 510(k) DEN200015

Name: FDA 510(k) clearance DEN200015
Creator: U.S. Food and Drug Administration
Published: 2020-07-30

Unknown

Roche Molecular Systems, Inc.

FDA 510(k) clearance DEN200015 for cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit, Unknown on 2020-07-30. Applicant: Roche Molecular Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code QLX
Device class: Class 2
Regulation: 21 CFR 866.3183
Advisory panel: Microbiology
Date received: 2020-03-02
Decision date: 2020-07-30
Decision: Unknown
Clearance type: Direct
Location: Pleasanton, CA, US

View on FDA.gov ↗

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K203220 — cobas BKV2021-01-29

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