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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 the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) 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. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.

When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for B. anthracis Real-time PCR Assay?

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

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 records listing Centers for Disease Control and Prevention 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.

K260812Francisella tularensis Real-time PCR AssayK252072Francisella tularensis Real-time PCR assayK243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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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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