COMBI SCAN100— 510(k) K061846

Substantially Equivalent

Analyticon Biotechnologies AG

FDA 510(k) clearance K061846 for COMBI SCAN100, Substantially Equivalent on 2007-04-06. 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: 2006-06-26
Decision date: 2007-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lichtenfels, Hessen, DE

Download summary PDF View on FDA.gov ↗

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