COMBI-SCREEN, MODELS 10SL AND 11SL— 510(k) K023885

Name: FDA 510(k) clearance K023885
Creator: U.S. Food and Drug Administration
Published: 2003-10-21

Substantially Equivalent

Analyticon Biotechnologies AG

FDA 510(k) clearance K023885 for COMBI-SCREEN, MODELS 10SL AND 11SL, Substantially Equivalent on 2003-10-21. Applicant: Analyticon Biotechnologies AG. Device class: 2.

Clearance details

Applicant: Analyticon Biotechnologies AG
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2002-11-21
Decision date: 2003-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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