Atlas FDA

MRG

46 FDA 510(k) clearances · Product code

154 daysmedian time to decision
290 days90th percentile
46clearances measured

FDA profile

Official device name
System, Test, Vitamin D
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1825
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 15 · 2022: 13 · 2023: 22 · 2024: 32 · 2025: 29 · 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (K232587)Shenzhen New Industries Biomedical Engineering Co., Ltd.2024-04-12
ALFIS Vitamin D, ALFIS-3 Analyzer (K221817)Immunostics Inc.,2023-09-22
Access 25(OH) Vitamin D Total (K223503)Beckman Coulter, Inc.2023-01-19
Elecsys Vitamin D total III (K210901)Roche Diagnostics2021-09-01
ADVIA Centaur Vitamin D Total (VitD) (K200509)Siemens Healthcare Diagnostics, Inc.2020-05-29
MAGLUMI 2000 25-OH Vitamin D (K191499)Shenzhen New Industries Biomedical Engineering Co., Ltd.2019-08-01
BioPlex 2200 25-OH Vitamin D Kit (K180577)Bio-Rad Laboratories2018-06-22
Diazyme EZ Vitamin D Assay (K172992)Diazyme Laboratories2018-01-11
LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298)Siemens Healthcare Diagnostics2017-03-16
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840)Roche Diagnostics2017-02-08
FREND Vitamin D Test System (K162754)Nanoentek USA, Inc.2017-01-12
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (K161831)Immunodiagnostic Systems , Ltd.2016-11-15
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375)Abbott Laboratories2016-08-12
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators (K153361)Fujirebio Diagnostics,Inc.2016-04-15
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270)Tosoh Bioscience, Inc.2015-10-26
25-Hydroxy Vitamin Ds EIA (K142351)Immunodiagnostic Systems , Ltd.2015-08-25
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D (K141114)Bio-Rad Laboratories2015-01-09
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst (K142373)Beckman Coulter, Inc.2014-12-22
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (K140554)Immunodiagnostic Systems , Ltd.2014-12-19
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. (K142362)Beckman Coulter, Inc.2014-12-19
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS (K141463)DiaSorin, Inc.2014-12-10
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA (K133156)Siemens Healthcare Diagnostics, Inc.2014-07-24
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET (K133410)Diazyme Laboratories2014-03-14
LIAISON 25 TOTAL-D (K132492)DiaSorin, Inc.2013-09-05
25-OH VITAMIN D ELISA (K123660)Euroimmun US2013-07-17
25OH VITAMIN D TOTAL ELISA TEST (K123364)Diasource Immunoassays, S.A.2013-07-15
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS (K123983)Qualigen, Inc.2013-07-03
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D (K123253)Immunodiagnostic Systems , Ltd.2013-06-18
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS (K121608)Ortho-Clinical Diagnostics, Inc.2013-02-15
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI (K123131)Tosoh Bioscience, Inc.2013-02-08
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA (K122420)Diazyme Laboratories2012-11-28
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546)Roche Diagnostics2012-07-24
LIAISON 25 OH VITAMIN D TOTAL ASSAY (K112725)DiaSorin, Inc.2012-01-20
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS (K110619)Biokit, S.A.2011-11-23
ADVIA CENTAUR VITAMIN D TOTAL ASSAY (K110586)Siemens Healthcare Diagnostics, Inc.2011-10-14
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, (K102432)Diazyme Laboratories2011-01-14
IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET (K091849)Immunodiagnostic Systems, Inc.2010-06-25
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST (K072536)Esa Biosciences, Inc.2008-05-07
LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 (K071480)DiaSorin, Inc.2007-10-01
1,25-DIHYDROXY VITAMIN D EIA (K051110)Immunodiagnostic Systems , Ltd.2005-07-06
GAMMA-B 1,25-DIHYDROXY VITAMIN D (K042519)Immunodiagnostic Systems , Ltd.2004-12-01
LIAISON 25 OH VITAMIN D (K032844)DiaSorin, Inc.2004-02-12
OCTEIA 25-HYDROXY VITAMIN D (K021163)Immunodiagnostic Systems , Ltd.2002-05-10
1,25-DIHYDROXYVITAMIN D125I RIA (K014030)DiaSorin, Inc.2002-03-26
GAMMA-B 25-HYDROXY VITAMIN D RIA (K991998)Immunodiagnostic Systems , Ltd.1999-09-17
INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567)Incstar Corp.1996-09-25

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Every clearance here is in the API, with alerts when new ones post.