JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136— 510(k) K100287

Name: FDA 510(k) clearance K100287
Creator: U.S. Food and Drug Administration
Published: 2010-07-06

Substantially Equivalent

U.S. Army Medical Material Development Command

FDA 510(k) clearance K100287 for JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136, Substantially Equivalent on 2010-07-06. Applicant: U.S. Army Medical Material Development Command. Device class: 2.

Clearance details

Applicant: U.S. Army Medical Material Development Command
Product code: Code NXD
Device class: Class 2
Regulation: 21 CFR 866.3332
Advisory panel: Microbiology
Date received: 2010-01-29
Decision date: 2010-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NXD

view all

K080570 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL2008-09-30
DEN060008 — INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET2006-02-03

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