Chrysalis Intelligence · Sponsors · Selux Diagnostics, Inc.

Selux Diagnostics, Inc.

Charlestown, MA, US · 4 510(k) clearances

Total clearances
4
2023-01-18 → 2025-03-28
Last 12 months
0
Product codes
2
Most recent
2025-03-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Class II Microbiology 2 2025-03-28
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class II Microbiology 2 2023-04-19
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-03-28 K244044 PBC Separator with Selux AST System QZX Class II Microbiology
2024-02-15 K223493 PBC Separator with Selux AST System QZX Class II Microbiology
2023-04-19 K211748 Selux AST System; Model AST Gen 1.0 LON Class II Microbiology
2023-01-18 K211759 Selux AST System; Model AST Gen 1.0 LON Class II Microbiology