MRGClass II
System, Test, Vitamin D
21 CFR 862.1825 / Clinical Chemistry
MRG is the FDA product code for System, Test, Vitamin D, a class II device type, regulated under 21 CFR 862.1825. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 25 recalls.
Classification record
- Product code
- MRG
- Device name
- System, Test, Vitamin D
- Regulation
- 21 CFR 862.1825
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 46
- Ingested recalls
- 25
Clearances, product code MRG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1999 | 1 |
| 2002 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 7 |
| 2014 | 6 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
Applicants with the most clearances
Product code MRG| Applicant | Clearances |
|---|---|
| Immunodiagnostic Systems Ltd. | 9 |
| Siemens Healthcare Diagnostics Inc. | 7 |
| Diasorin Inc. | 6 |
| Diazyme Laboratories, Inc. | 4 |
| Roche Diagnostics GmbH | 3 |
| Bio-Rad Laboratories Inc. | 2 |
| Shenzhen New Industries Biomedical Engineering Co.,Ltd | 2 |
| Tosoh Bioscience Inc | 2 |
| Abbott Medical | 1 |
| Biokit, S.A. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 7051395 Canada Inc dba Hta Direct Sourcing
- Abbott Ireland Diagnostics Division
- Abbott Medical
- ACRO BIOTECH Inc.
- Affimedix, Inc.
- Alius Scientific,LLC
- American Laboratory Products Company
- Beckman Coulter Ireland Inc
- Bialex Lab
- Bio-Rad Laboratories Inc.
- CTK Biotech, Inc.
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
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