510(k) K193419

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 27, 2020

Date Received

December 9, 2019

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Mass Spectrometry, Microorganism Identification, Blood Culture

Device Class

Class II

Regulation Number

866.3378

Review Panel

MI

Submission Type

Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.