25-HYDROXYVITAMIN D 125I RIA KIT— 510(k) K983617

Name: FDA 510(k) clearance K983617
Creator: U.S. Food and Drug Administration
Published: 1998-11-16

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K983617 for 25-HYDROXYVITAMIN D 125I RIA KIT, Substantially Equivalent on 1998-11-16. Applicant: DiaSorin, Inc.. Device class: 1.

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LCI
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1998-10-15
Decision date: 1998-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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