25OH VITAMIN D TOTAL ELISA TEST— 510(k) K123364

Name: FDA 510(k) clearance K123364
Creator: U.S. Food and Drug Administration
Published: 2013-07-15

Substantially Equivalent

Diasource Immunoassays, S.A.

FDA 510(k) clearance K123364 for 25OH VITAMIN D TOTAL ELISA TEST, Substantially Equivalent on 2013-07-15. Applicant: Diasource Immunoassays, S.A.. Device class: 2.

Clearance details

Applicant: Diasource Immunoassays, S.A.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2012-11-01
Decision date: 2013-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K123364

K-number listed on FDA's recall record

Z-0410-2019 — R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971Class III·Terminated·R & D Systems, Inc.·20180911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123364.

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