OneDraw A1C Test System— 510(k) K183230

Substantially Equivalent

Drawbridge Health, Inc.

FDA 510(k) clearance K183230 for OneDraw A1C Test System, Substantially Equivalent on 2019-08-15. Applicant: Drawbridge Health, Inc..

Clearance details

Applicant
Drawbridge Health, Inc.
Product code
Code LCP
Advisory panel
Hematology
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.