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FDA 510(k)

BioFire Blood Culture Identification 2 (BCID2) Panel

K-Number: K193519 · 2020-03-18

ApplicantBiofire Diagnostics, LLC
Decision Date2020-03-18
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioFire Blood Culture Identification 2 (BCID2) Panel is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2020-03-18 under approval number K193519. 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 BioFire Blood Culture Identification 2 (BCID2) Panel?

BioFire Blood Culture Identification 2 (BCID2) Panel is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K193519.

When was BioFire Blood Culture Identification 2 (BCID2) Panel approved by the FDA?

BioFire Blood Culture Identification 2 (BCID2) Panel received FDA 510(k) clearance on 2020-03-18, under approval number K193519.

What company makes BioFire Blood Culture Identification 2 (BCID2) Panel?

BioFire Blood Culture Identification 2 (BCID2) Panel is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for BioFire Blood Culture Identification 2 (BCID2) Panel?

The FDA product code for BioFire Blood Culture Identification 2 (BCID2) Panel is PEN.

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Related Devices (Code: PEN)

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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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