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FDA 510(k)

Rickettsia Real-time PCR Assay

K-Number: K170940 · 2017-06-29

ApplicantCenters For Disease Control and Prevention (CDC)
Decision Date2017-06-29
Product CodePVQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Rickettsia Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2017-06-29 under 510(k) 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. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K170940.

When did Rickettsia Real-time PCR Assay receive FDA 510(k) clearance?

Rickettsia Real-time PCR Assay received FDA 510(k) clearance on 2017-06-29, under 510(k) number K170940.

Who is the listed applicant for Rickettsia Real-time PCR Assay?

The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) as the applicant. This does not by itself establish the device manufacturer.

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 records listing Centers For Disease Control and Prevention (CDC) 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.

K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,K161556CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

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.

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