ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01— 510(k) K082953

Name: FDA 510(k) clearance K082953
Creator: U.S. Food and Drug Administration
Published: 2008-12-22

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K082953 for ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01, Substantially Equivalent on 2008-12-22. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant: Biokit, S.A.
Product code: Code KXT
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2008-10-03
Decision date: 2008-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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