Chrysalis Intelligence · Sponsors · ACON Laboratories, Inc.

ACON Laboratories, Inc.

San Diego, CA, US · 9 510(k) clearances

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Total clearances
9
2020-08-20 → 2026-07-10
Last 12 months
4
Product codes
5
Most recent
2026-07-10
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 3 2026-07-10
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Class II Clinical Chemistry 2 2024-05-31
QYT Over-The-Counter Covid-19 Antigen Test Class II Microbiology 2 2024-04-19
GTY — — — 1 2025-11-26
NBW System, Test, Blood Glucose, Over The Counter Class II Clinical Chemistry 1 2025-10-10
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-07-10 K261212 Flowflex Plus RSV + Flu A/B + COVID Rapid Test SCA Class II Microbiology
2025-11-26 K251697 Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip GTY — —
2025-10-22 K251749 Flowflex Plus RSV + Flu A/B + COVID Home Test SCA Class II Microbiology
2025-10-10 K250085 On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System NBW Class II Clinical Chemistry
2025-05-10 K250377 Flowflex Plus COVID-19 + Flu A/B Home Test SCA Class II Microbiology
2024-05-31 K232715 Distinct® Digital Pregnancy Test LCX Class II Clinical Chemistry
2024-04-19 K233373 Flowflex® Plus COVID-19 Home Test QYT Class II Microbiology
2023-11-09 K230828 Flowflex COVID-19 Antigen Home Test QYT Class II Microbiology
2020-08-20 K193318 Distinct® Early Detection Pregnancy Test LCX Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence