BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K-Number: K180438 · 2018-03-20
ApplicantBd
Decision Date2018-03-20
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is a medical device manufactured by Bd. It received FDA 510(k) clearance on 2018-03-20 under approval number K180438. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is a medical device that received FDA 510(k) clearance on 2018-03-20. It is manufactured by Bd. The 510(k) number is K180438.
When was BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit approved by the FDA?
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit received FDA 510(k) clearance on 2018-03-20, under approval number K180438.
What company makes BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is manufactured by Bd.
What is the FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?
The FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is PSZ.
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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.