# ACON Laboratories, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 93 (1998–2026): 93 510(k) clearances
- Names in FDA's records: ACON Laboratories, Inc. (86); Acon Laboratories Co. (6); Acon Laboratories (1)
- Product codes: NBW (13), LCX (10), DKZ (6), DJG (6), JHI (5), GTY (4), LDJ (4), SCA (3), LAF (3), DIO (3), DIS (3), CGA (2)
- 510(k) review time since 2016: median 89 days, against 132 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 92 (53 its own); citations of its devices by later devices: 147 (53 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Princeton BioMeditech Corp.: 6 (https://510kreport.com/company/princeton-biomeditech)
- Selfcare, Inc.: 4 (https://510kreport.com/company/selfcare)
- Bayer Healthcare, LLC: 3 (https://510kreport.com/company/bayer-healthcare)
- Heraeus Kulzer, Inc.: 3 (https://510kreport.com/company/heraeus-kulzer)
- Bio-Rad, Diagnostics Grp.: 2 (https://510kreport.com/company/bio-rad-diagnostics-grp)
- Quidel Corp.: 2 (https://510kreport.com/company/quidel)
- Bayer Corp.: 2 (https://510kreport.com/company/bayer)
- Enzymatics C/O Burditt,Bowles,Radzius & Ruberry: 1 (https://510kreport.com/company/enzymatics-c-o-burditt-bowles-radzius-ruberry)

## Firms that cite its devices most
- Guangzhou Wondfo Biotech Co., Ltd.: 21 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Innovacon, Inc.: 7 (https://510kreport.com/company/innovacon)
- W.H.P.M., Inc.: 7 (https://510kreport.com/company/whpm)
- Polymed Therapeutics, Inc.: 7 (https://510kreport.com/company/polymed-therapeutics)
- Applied Dna Technologies, Inc.: 6 (https://510kreport.com/company/applied-dna-technologies)
- Nano-Ditech Corporation: 5 (https://510kreport.com/company/nano-ditech)
- Quantrx Biomedical Corporation: 4 (https://510kreport.com/company/quantrx-biomedical)
- Eoshealth, Inc.: 2 (https://510kreport.com/company/eoshealth)

## Its most-cited devices
- K020771: Acon One Step Drug Screen Test Card (2002), cited by 9
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device (2002), cited by 7
- K230828: Flowflex COVID-19 Antigen Home Test (2023), cited by 7
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device (2001), cited by 6
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device (2001), cited by 6
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine) (2001), cited by 6

## Recent decisions
- K261212: Flowflex Plus RSV + Flu A/B + COVID Rapid Test (Jul 10, 2026)
- K251697: Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (Nov 26, 2025)
- K251749: Flowflex Plus RSV + Flu A/B + COVID Home Test (Oct 22, 2025)
- K250085: On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (Oct 10, 2025)
- K250377: Flowflex Plus COVID-19 + Flu A/B Home Test (May 10, 2025)
- K232715: Distinct® Digital Pregnancy Test (May 31, 2024)
- K233373: Flowflex® Plus COVID-19 Home Test (Apr 19, 2024)
- K230828: Flowflex COVID-19 Antigen Home Test (Nov 9, 2023)

Source page: https://510kreport.com/company/acon-laboratories