OCTEIA 25-HYDROXY VITAMIN D— 510(k) K021163

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

2002-04-11

Decision date

2002-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boldon, Tyne & Wear, GB

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• Z-0697-2013 — 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.Class II·Terminated·IDS (Immunodiagnostic Systems Ltd.)·20121107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021163.