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510(k) K192665

Accelerate Pheno System, Accelerate PhenoTest BC Kit by Accelerate Diagnostics, Inc. — Product Code PRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2020
Date Received
September 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positive Blood Culture Identification And Ast Kit
Device Class
Class II
Regulation Number
866.1650
Review Panel
MI
Submission Type

Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.

Other clearances by Accelerate Diagnostics, Inc.

  • K240854 — Accelerate Arc System (September 26, 2024)

Other clearances for product code PRH

  • DEN160032 — Accelerate Pheno system, Accelerate Phenotest BC Kit (February 23, 2017)