JBAIDS PLAGUE DETECTION KIT— 510(k) K131729

Name: FDA 510(k) clearance K131729
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Substantially Equivalent

Biofire Diagnostics, Inc.

FDA 510(k) clearance K131729 for JBAIDS PLAGUE DETECTION KIT, Substantially Equivalent on 2013-07-31. Applicant: Biofire Diagnostics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Biofire Diagnostics, Inc.
Product code: Code OIH
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-06-12
Decision date: 2013-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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