Chrysalis Intelligence · Sponsors · Access Bio, Inc.

Access Bio, Inc.

Monroe Township, NJ, US · 3 510(k) clearances

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Total clearances
3
2020-02-18 → 2025-08-22
Last 12 months
0
Product codes
3
Most recent
2025-08-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SCA Multi-Analyte Respiratory Virus Antigen Detection Test Class II Microbiology 1 2025-08-22
QYT Over-The-Counter Covid-19 Antigen Test Class II Microbiology 1 2025-01-29
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Class II Microbiology 1 2020-02-18
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-08-22 K251604 CareSuperb COVID-19/Flu A&B Antigen Combo Home Test SCA Class II Microbiology
2025-01-29 K241915 CareSuperb™ COVID-19 Antigen Home Test QYT Class II Microbiology
2020-02-18 K191514 CareStart Flu A&B Plus PSZ Class II Microbiology
Data source: openFDA · Generated 2026-08-23 08:58 · Last ingest 2026-08-23T12:58:54.311501 · Pipeline: Chrysalis Intelligence