Chrysalis Intelligence · Sponsors · Affinity Biosensors, LLC

Affinity Biosensors, LLC

Santa Barbara, CA, US · 3 510(k) clearances

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Total clearances
3
2024-04-02 → 2025-10-27
Last 12 months
1
Product codes
1
Most recent
2025-10-27
Name variants in FDA filings: Affinity Biosensors, LLC / Affinity Biosensors
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Class II Microbiology 3 2025-10-27
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-10-27 K251875 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system SAN Class II Microbiology
2024-10-23 K241324 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system SAN Class II Microbiology
2024-04-02 K211815 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System SAN Class II Microbiology
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence