510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140426Substantially Equivalent

Anthracis Real-Time PCR Assay

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

K140426 is the FDA 510(k) clearance record for ANTHRACIS REAL-TIME PCR ASSAY, a class II device, cleared for Centers For Disease Control and Prevention (CDC) on under FDA product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis). FDA's definition for product code NHT reads: "An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth". FDA records list 6 510(k) clearances for Centers For Disease Control and Prevention (CDC), from to . As of , FDA records show no recalls naming K140426.

Clearance record

Decision date
Received
(92 days to decision)
Product code
NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Centers For Disease Control and Prevention (CDC) 1600 Clifton Rd. NE, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHT

Trailing 12 months

FDA records hold no clearances under product code NHT in the trailing twelve months.

FDA records show no clearances under product code NHT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260