Data / Medical devices / United States / Acon Laboratories, Inc.

Acon Laboratories, Inc.: FDA-registered device maker in San Diego, CA, United States, 27 510(k) clearances

Acon Laboratories, Inc. is registered with the FDA (registration 2531491) in San Diego, CA, United States. It lists 31 device types. The FDA files 27 510(k) clearances under its listings, the newest dated November 26, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

2531491

FEI number

3003516723

Address

9440 Carroll Park Dr, San Diego, CA, United States, 92121

Owner or operator

ACON Laboratories, Inc. (9063887)

Roles

Contract manufacturer, Manufacturer, Specification developer

First device listed

October 13, 2006

Registered through

2027

Brand names listed

ACON URINALYSIS REAGENT STRIPS, AimStrip Hb Hemoglobin (Hb) Testing System, CAREONE Express Blood Glucose Monitoring System, CLIAwaived Inc. Hemoglobin Testing System, Cliawaived Inc. Auto Urinalysis Reagent Strips, D-Care, Diathrive Blood Glucose Monitoring System, Distinct® Early Detection Pregnancy Test and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

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Updated November 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.