CORTISOL ELISA— 510(k) K062626

Substantially Equivalent

Ibl-Hamburg GmbH

FDA 510(k) clearance K062626 for CORTISOL ELISA, Substantially Equivalent on 2006-12-20. Applicant: Ibl-Hamburg GmbH. Device class: 2.

Clearance details

Applicant: Ibl-Hamburg GmbH
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2006-09-05
Decision date: 2006-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.