ABBOTT VISION(TM) GLYCATED HB— 510(k) K904027

Name: FDA 510(k) clearance K904027
Creator: U.S. Food and Drug Administration
Published: 1991-02-07

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K904027 for ABBOTT VISION(TM) GLYCATED HB, Substantially Equivalent on 1991-02-07. 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: 1990-08-30
Decision date: 1991-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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