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510(k) K244044

PBC Separator with Selux AST System by Selux Diagnostics, Inc. — Product Code QZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2025
Date Received
December 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Device Class
Class II
Regulation Number
866.1650
Review Panel
MI
Submission Type

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

Other clearances by Selux Diagnostics, Inc.

  • K223493 — PBC Separator with Selux AST System (February 15, 2024)
  • K211748 — Selux AST System; Model AST Gen 1.0 (April 19, 2023)
  • K211759 — Selux AST System; Model AST Gen 1.0 (January 18, 2023)

Other clearances for product code QZX

  • K223493 — PBC Separator with Selux AST System (February 15, 2024)
  • K231536 — eQUANT System (February 8, 2024)