AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT— 510(k) K944490

Name: FDA 510(k) clearance K944490
Creator: U.S. Food and Drug Administration
Published: 1994-12-09

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K944490 for AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT, Substantially Equivalent on 1994-12-09. Applicant: Wallac OY. Device class: 1.

Clearance details

Applicant: Wallac OY
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1994-09-13
Decision date: 1994-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turku, FI

Download summary PDF View on FDA.gov ↗

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