JBAIDS TULAREMIA DETECTION KIT— 510(k) K131936

Name: FDA 510(k) clearance K131936
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Substantially Equivalent

Biofire Diagnostics, Inc.

FDA 510(k) clearance K131936 for JBAIDS TULAREMIA DETECTION KIT, Substantially Equivalent on 2013-07-31. Applicant: Biofire Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, Inc.
Product code: Code OEH
Device class: Class 2
Regulation: 21 CFR 866.3280
Advisory panel: Microbiology
Date received: 2013-06-27
Decision date: 2013-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OEH

view all

K072547 — JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-01242007-12-19

More clearances from Biofire Diagnostics, Inc.

view all

K131930 — JBAIDS ANTHRAX DETECTION KIT2013-08-05
K131729 — JBAIDS PLAGUE DETECTION KIT2013-07-31
K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL2013-06-21
K123620 — FILMARRAY RESPIRATORY PANEL (RP)2013-02-11

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