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FDA 510(k)

JBAIDS PLAGUE DETECTION KIT

K-Number: K131729 · 2013-07-31

ApplicantBiofire Diagnostics, Inc.
Decision Date2013-07-31
Product CodeOIH
DecisionSubstantially Equivalent

Device Summary

JBAIDS PLAGUE 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 K131729. The device is classified under product code OIH. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JBAIDS PLAGUE DETECTION KIT?

JBAIDS PLAGUE 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 K131729.

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

JBAIDS PLAGUE DETECTION KIT received FDA 510(k) clearance on 2013-07-31, under 510(k) number K131729.

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

The FDA product code for JBAIDS PLAGUE DETECTION KIT is OIH.

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

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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