510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K244044Substantially Equivalent

PBC Separator with Selux AST System

Selux Diagnostics, Inc., Charlestown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K244044 is the FDA 510(k) clearance record for PBC Separator with Selux AST System, a class II device, cleared for Selux Diagnostics, Inc. on under FDA product code QZX (Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing). FDA's definition for product code QZX reads: "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...". FDA records list 4 510(k) clearances for Selux Diagnostics, Inc., from to . As of , FDA records show no recalls naming K244044.

Clearance record

Decision date
Received
(88 days to decision)
Product code
QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Regulation
21 CFR 866.1650
Device class
Class II
Review panel
Microbiology
Applicant
Selux Diagnostics, Inc. 56 Roland St., Charlestown MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZX

Trailing 12 months

FDA records hold no clearances under product code QZX in the trailing twelve months.

FDA records show no clearances under product code QZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260