GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC— 510(k) K143592

Name: FDA 510(k) clearance K143592
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Substantially Equivalent

The Surgeon General, Department of the Army

FDA 510(k) clearance K143592 for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC, Substantially Equivalent on 2015-04-16. Applicant: The Surgeon General, Department of the Army. Device class: 2.

Clearance details

Applicant: The Surgeon General, Department of the Army
Product code: Code NVQ
Device class: Class 2
Regulation: 21 CFR 866.3045
Advisory panel: Microbiology
Date received: 2014-12-18
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NVQ

view all

K051794 — GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS2005-08-16

More clearances from The Surgeon General, Department of the Army

view all

K140387 — Burn Resuscitation Decision Support System - Clinical (BRDSS-C)2014-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.