Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

K-Number: K202215 · 2020-09-02

ApplicantRoche Molecular Systems, Inc.
Decision Date2020-09-02
Product CodeQMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K202215. The device is classified under product code QMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K202215.

When did cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit receive FDA 510(k) clearance?

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit received FDA 510(k) clearance on 2020-09-02, under 510(k) number K202215.

Who is the listed applicant for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

The FDA product code for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is QMI.

Other records listing Roche Molecular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260021cobas® BV/CVK260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection system

View all 47 devices →

Related Devices (Code: QMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241921Alinity m BKVAbbott Molecular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑