TDX(R) II ANALYZER— 510(k) K864319

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K864319 for TDX(R) II ANALYZER, Substantially Equivalent on 1986-12-16. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1986-11-03
Decision date: 1986-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, 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.