DeviceClearance

Alere Afinion HbA1c and ACR on Afinion 2 analyzer— 510(k) K171650

Substantially Equivalent

Abbott Rapid Diagnostics

FDA 510(k) clearance K171650 for Alere Afinion HbA1c and ACR on Afinion 2 analyzer, Substantially Equivalent on 2017-11-21. Applicant: Abbott Rapid Diagnostics.

Clearance details

Applicant
Abbott Rapid Diagnostics
Product code
Code LCP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.