510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260812Substantially Equivalent

Francisella tularensis Real-time PCR Assay

Centers for Disease Control and Prevention, Atlanta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260812 is the FDA 510(k) clearance record for Francisella tularensis Real-time PCR Assay, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code SGA (Biothreat Microbial Agent Nucleic Acid Detection Test). FDA's definition for product code SGA reads: "A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming K260812.

Clearance record

Decision date
Received
(17 days to decision)
Product code
SGA Biothreat Microbial Agent Nucleic Acid Detection Test
Regulation
21 CFR 866.4000
Device class
Class II
Review panel
Immunology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd., NE, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGA

Trailing 12 months
1 clearance under product code SGA in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260