DeviceClearance

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis— 510(k) K170587

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K170587 for On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis, Substantially Equivalent on 2017-07-06. Applicant: ACON Laboratories, Inc..

Clearance details

Applicant
ACON Laboratories, Inc.
Product code
Code JIN
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.