IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET— 510(k) K091849

Name: FDA 510(k) clearance K091849
Creator: U.S. Food and Drug Administration
Published: 2010-06-25

Substantially Equivalent

Immunodiagnostic Systems, Inc.

FDA 510(k) clearance K091849 for IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET, Substantially Equivalent on 2010-06-25. Applicant: Immunodiagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Immunodiagnostic Systems, Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2009-06-22
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Hills, AZ, US

Download summary PDF View on FDA.gov ↗

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