ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS— 510(k) K110619

Clearance details

Applicant

Biokit, S.A.

Product code

Code MRG

Device class

Class 2

Regulation

21 CFR 862.1825

Advisory panel

Clinical Chemistry

Date received

2011-03-03

Decision date

2011-11-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Llissa D'Amunt, Barcelona, ES

• 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

• K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls2025-02-12
• K233605 — ADVIA Centaur EBV-EBNA IgG2024-08-07
• K233606 — ADVIA Centaur EBV-VCA IgM2024-08-07
• K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls2023-09-20
• K214068 — Quantia IgE2023-02-21

• Z-0698-2013 — Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.Class II·Terminated·Abbott Laboratories·20121212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110619.