FDA Product Code MRG: System, Test, Vitamin D
Leading manufacturers include Roche Diagnostics, Immunostics Inc., and Beckman Coulter, Inc..
46
Total
46
Cleared
182d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared System, Test, Vitamin D Devices (Product Code MRG)
46 devices
Cleared
Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Chemistry
231d
Cleared
Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
Immunostics Inc.,
Chemistry
457d
Cleared
Jan 19, 2023
Access 25(OH) Vitamin D Total
Beckman Coulter, Inc.
Chemistry
58d
Cleared
Sep 01, 2021
Elecsys Vitamin D total III
Roche Diagnostics
Chemistry
159d
About Product Code MRG - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code MRG since 1996, with 46 receiving FDA clearance (average review time: 182 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
MRG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →