GAMMA-B 1,25-DIHYDROXY VITAMIN D— 510(k) K042519

Name: FDA 510(k) clearance K042519
Creator: U.S. Food and Drug Administration
Published: 2004-12-01

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K042519 for GAMMA-B 1,25-DIHYDROXY VITAMIN D, Substantially Equivalent on 2004-12-01. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2004-09-16
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boldon, Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

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