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FDA 510(k)

Francisella tularensis Real-time PCR Assay

K-Number: K260812 · 2026-03-30

ApplicantCenters for Disease Control and Prevention
Decision Date2026-03-30
Product CodeSGA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Francisella tularensis Real-time PCR Assay is a medical device manufactured by Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2026-03-30 under approval number K260812. 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 2026-03-30. It is manufactured by Centers for Disease Control and Prevention. The 510(k) number is K260812.

When was Francisella tularensis Real-time PCR Assay approved by the FDA?

Francisella tularensis Real-time PCR Assay received FDA 510(k) clearance on 2026-03-30, under approval number K260812.

What company makes Francisella tularensis Real-time PCR Assay?

Francisella tularensis Real-time PCR Assay is manufactured by Centers for Disease Control and Prevention.

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.

Related PubMed Literature

PMID: 32750323 Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices. Gastrointestinal endoscopy (2021)

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Related Devices (Code: SGA)

K252072Francisella 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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