TDX TOTAL ESTRIOL— 510(k) K844511

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K844511 for TDX TOTAL ESTRIOL, Substantially Equivalent on 1985-01-18. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1984-11-20
Decision date: 1985-01-18
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.