IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set— 510(k) K161831

Name: FDA 510(k) clearance K161831
Creator: U.S. Food and Drug Administration
Published: 2016-11-15

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K161831 for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set, Substantially Equivalent on 2016-11-15. 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: 2016-07-05
Decision date: 2016-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRG

view all

K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer2024-04-12
K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer2023-09-22
K223503 — Access 25(OH) Vitamin D Total2023-01-19
K210901 — Elecsys Vitamin D total III2021-09-01
K200509 — ADVIA Centaur Vitamin D Total (VitD)2020-05-29

More clearances from Immunodiagnostic Systems , Ltd.

view all

K202136 — IDS Cortisol2021-04-13
K200475 — IDS-iSYS Ostase BAP2020-09-30
K190121 — IDS SHBG2019-06-17
K161158 — IDS-iSYS Intact PTHN2017-01-31
K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers2016-05-17

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