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FDA 510(k)

JBAIDS TULAREMIA DETECTION KIT

K-Number: K131936 · 2013-07-31

ApplicantBiofire Diagnostics, Inc.
Decision Date2013-07-31
Product CodeOEH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JBAIDS TULAREMIA 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 2013-07-31 under 510(k) number K131936. The device is classified under product code OEH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JBAIDS TULAREMIA DETECTION KIT?

JBAIDS TULAREMIA DETECTION KIT is a medical device that received FDA 510(k) clearance on 2013-07-31. The listed applicant is Biofire Diagnostics, Inc.. The 510(k) number is K131936.

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

JBAIDS TULAREMIA DETECTION KIT received FDA 510(k) clearance on 2013-07-31, under 510(k) number K131936.

Who is the listed applicant for JBAIDS TULAREMIA 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 TULAREMIA DETECTION KIT?

The FDA product code for JBAIDS TULAREMIA DETECTION KIT is OEH.

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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.

K131930JBAIDS ANTHRAX DETECTION KITK131729JBAIDS PLAGUE DETECTION KITK130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELK123620FILMARRAY RESPIRATORY PANEL (RP)

Related Devices (Code: OEH)

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.

K072547JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124Idaho 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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