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FDA 510(k)

FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

K-Number: K130914 · 2013-06-21

ApplicantBiofire Diagnostics, Inc.
Decision Date2013-06-21
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL 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 2013-06-21 under 510(k) number K130914. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL?

FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Biofire Diagnostics, Inc.. The 510(k) number is K130914.

When did FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL receive FDA 510(k) clearance?

FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130914.

Who is the listed applicant for FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL?

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 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL?

The FDA product code for FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL is PEN.

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.

K131930JBAIDS ANTHRAX DETECTION KITK131729JBAIDS PLAGUE DETECTION KITK131936JBAIDS TULAREMIA DETECTION KITK123620FILMARRAY RESPIRATORY PANEL (RP)

Related Devices (Code: PEN)

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.

K262168QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbHK243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex CorporationK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLCK213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.

Official Source

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

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