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FDA 510(k)

BacterioScan 216Dx System

K-Number: K172412 · 2018-05-01

ApplicantBacterioscan, Inc.
Decision Date2018-05-01
Product CodeQBQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BacterioScan 216Dx System is the device name listed in this FDA 510(k) record. The listed applicant is Bacterioscan, Inc.. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K172412. The device is classified under product code QBQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BacterioScan 216Dx System?

BacterioScan 216Dx System is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Bacterioscan, Inc.. The 510(k) number is K172412.

When did BacterioScan 216Dx System receive FDA 510(k) clearance?

BacterioScan 216Dx System received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172412.

Who is the listed applicant for BacterioScan 216Dx System?

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

What is the FDA product code for BacterioScan 216Dx System?

The FDA product code for BacterioScan 216Dx System is QBQ.

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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