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FDA 510(k)

B. anthracis Real-time PCR Assay

K-Number: K192871 · 2019-11-07

ApplicantCenters for Disease Control and Prevention
Decision Date2019-11-07
Product CodeNHT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

B. anthracis Real-time PCR Assay is a medical device manufactured by Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under approval number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B. anthracis Real-time PCR Assay?

B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Centers for Disease Control and Prevention. The 510(k) number is K192871.

When was B. anthracis Real-time PCR Assay approved by the FDA?

B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under approval number K192871.

What company makes B. anthracis Real-time PCR Assay?

B. anthracis Real-time PCR Assay is manufactured by Centers for Disease Control and Prevention.

What is the FDA product code for B. anthracis Real-time PCR Assay?

The FDA product code for B. anthracis Real-time PCR Assay is NHT.

Other Devices by Centers for Disease Control and Prevention

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Official Source

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

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