Rickettsia Real-time PCR Assay
K-Number: K170940 · 2017-06-29
Decision Date2017-06-29
Product CodePVQ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Rickettsia Real-time PCR Assay is a medical device manufactured by Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2017-06-29 under approval number K170940. The device is classified under product code PVQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rickettsia Real-time PCR Assay?
Rickettsia Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2017-06-29. It is manufactured by Centers For Disease Control and Prevention (CDC). The 510(k) number is K170940.
When was Rickettsia Real-time PCR Assay approved by the FDA?
Rickettsia Real-time PCR Assay received FDA 510(k) clearance on 2017-06-29, under approval number K170940.
What company makes Rickettsia Real-time PCR Assay?
Rickettsia Real-time PCR Assay is manufactured by Centers For Disease Control and Prevention (CDC).
What is the FDA product code for Rickettsia Real-time PCR Assay?
The FDA product code for Rickettsia Real-time PCR Assay is PVQ.
Other Devices by Centers For Disease Control and Prevention (CDC)
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.