BacterioScan 216Dx System— 510(k) K172412

Substantially Equivalent

Bacterioscan, Inc.

FDA 510(k) clearance K172412 for BacterioScan 216Dx System, Substantially Equivalent on 2018-05-01. Applicant: Bacterioscan, Inc.. Device class: 1.

Clearance details

Applicant
Bacterioscan, Inc.
Product code
Code QBQ
Device class
Class 1
Regulation
21 CFR 866.2560
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saint Louis, MO, US
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