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FDA 510(k)

Francisella tularensis Real-time PCR assay

K-Number: K252072 · 2025-09-30

ApplicantCenters for Disease Control and Prevention
Decision Date2025-09-30
Product CodeSGA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Francisella tularensis 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 2025-09-30 under 510(k) number K252072. The device is classified under product code SGA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Francisella tularensis Real-time PCR assay?

Francisella tularensis Real-time PCR assay is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K252072.

When did Francisella tularensis Real-time PCR assay receive FDA 510(k) clearance?

Francisella tularensis Real-time PCR assay received FDA 510(k) clearance on 2025-09-30, under 510(k) number K252072.

Who is the listed applicant for Francisella tularensis 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 Francisella tularensis Real-time PCR assay?

The FDA product code for Francisella tularensis Real-time PCR assay is SGA.

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 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 SetK221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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Related Devices (Code: SGA)

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 AssayCenters for Disease Control and Prevention

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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