510(k) clearances

Francisella tularensis Real-time PCR Assay

Centers for Disease Control and Prevention · Immunology

K260812Substantially EquivalentSpecialSGA
Open FDA's page for this record
Third party flag
N
City
Atlanta
Advisory committee description
Immunology
Address 1
1600 Clifton Rd., NE
Address 2
Ms H24-2
Statement or summary
Summary
Product code
SGA
Zip code
30329
Applicant
Centers for Disease Control and Prevention
Decision date
2026-03-30
Decision code
SESE
Country code
US
Device name
Francisella tularensis Real-time PCR Assay
Advisory committee
IM
Contact
Jasmine Chaitram
K number
K260812
State
GA
Date received
2026-03-13
Review advisory committee
MI
Postal code
30329
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Biothreat Microbial Agent Nucleic Acid Detection Test
Medical specialty description
Immunology
Regulation number
866.4000
Device class
2
Registration number
1050190
FEI number
1050190
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.