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FDA 510(k)

JBAIDS ANTHRAX DETECTION KIT

K-Number: K131930 · 2013-08-05

ApplicantBiofire Diagnostics, Inc.
Decision Date2013-08-05
Product CodeNHT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JBAIDS ANTHRAX DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-08-05 under 510(k) number K131930. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JBAIDS ANTHRAX DETECTION KIT?

JBAIDS ANTHRAX DETECTION KIT is a medical device that received FDA 510(k) clearance on 2013-08-05. The listed applicant is Biofire Diagnostics, Inc.. The 510(k) number is K131930.

When did JBAIDS ANTHRAX DETECTION KIT receive FDA 510(k) clearance?

JBAIDS ANTHRAX DETECTION KIT received FDA 510(k) clearance on 2013-08-05, under 510(k) number K131930.

Who is the listed applicant for JBAIDS ANTHRAX DETECTION KIT?

The FDA 510(k) record lists Biofire Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JBAIDS ANTHRAX DETECTION KIT?

The FDA product code for JBAIDS ANTHRAX DETECTION KIT is NHT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Biofire Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131729JBAIDS PLAGUE DETECTION KITK131936JBAIDS TULAREMIA DETECTION KITK130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELK123620FILMARRAY RESPIRATORY PANEL (RP)

Related Devices (Code: NHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192871B. anthracis Real-time PCR AssayCenters for Disease Control and PreventionK072631JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123Idaho Technology, Inc.K071188MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEMIdaho Technology, Inc.K051713JBAIDS ANTHRAC DETECTION SYSTEMIdaho Technology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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