ABBOTT TDX/TDXFLX TT4— 510(k) K925109

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K925109 for ABBOTT TDX/TDXFLX TT4, Substantially Equivalent on 1993-01-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-10-09
Decision date: 1993-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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