TDX ANALYZER W/NEPHELOMETRY CAROUSEL— 510(k) K851253

Name: FDA 510(k) clearance K851253
Creator: U.S. Food and Drug Administration
Published: 1985-04-30

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K851253 for TDX ANALYZER W/NEPHELOMETRY CAROUSEL, Substantially Equivalent on 1985-04-30. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JQX
Device class: Class 1
Regulation: 21 CFR 862.2700
Advisory panel: Clinical Chemistry
Date received: 1985-03-28
Decision date: 1985-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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