ABBOTT ARCHITECT GLYCATED HEMOGLOBIN— 510(k) K991483

Name: FDA 510(k) clearance K991483
Creator: U.S. Food and Drug Administration
Published: 1999-11-01

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K991483 for ABBOTT ARCHITECT GLYCATED HEMOGLOBIN, Substantially Equivalent on 1999-11-01. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1999-04-28
Decision date: 1999-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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