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B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention vs CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention: FDAPulse comparison

B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention's review days of 89 is 3.0x CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention's 30 (29th percentile). B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention is dated 2026-10-07; CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention 2026-09-30.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention compare to CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention?

FieldB. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and PreventionCDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention
Record510(k) clearance510(k) clearance
510(k) numberK262368K263035
DeviceB. anthracis Real-time PCR AssayCDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
ApplicantCenters for Disease Control and PreventionCenters for Disease Control and Prevention
Specialty / panelMicrobiologyMicrobiology
Product codeNHTOZE
Device class22
Clearance typeTraditionalSpecial
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-07-102026-08-31
Decision date2026-10-072026-09-30
Review time (days)8930
Third-party reviewNoNo
Applicant locationAtlanta, GA, USAtlanta, GA, US
amount percentile29th10th
Predicate Speed & CAPA Advisory Opportunity Score36/10041/100
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Official records: B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention · CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention

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