510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051794Substantially Equivalent

Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis

Office of the Surgeon General, U.S. Army, Fort Detrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051794 is the FDA 510(k) clearance record for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS, a class II device, cleared for Office of the Surgeon General, U.S. Army on under FDA product code NVQ (Bacteriophage And Controls, B. Anthracis Lysis). FDA's definition for product code NVQ reads: "A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth...". FDA records list one 510(k) clearance for Office of the Surgeon General, U.S. Army. As of , FDA records show no recalls naming K051794.

Clearance record

Decision date
Received
(46 days to decision)
Product code
NVQ Bacteriophage And Controls, B. Anthracis Lysis
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Office of the Surgeon General, U.S. Army 1436 Porter St., Fort Detrick MD
510(k) summary
Statement
Third party review
No

Clearances, product code NVQ

Trailing 12 months

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

FDA records show no clearances under product code NVQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVQ, 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