510(k) K122420
- Device
- DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K122420
- Product code
- MRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-28
- Date received
- 2012-08-09
- Regulation
- 862.1825
- Classification name
- System, Test, Vitamin D
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 3009335633
- 3032705
- 3005094123
- 3010610113
- 3002800697
- 1063851
- 3005360469
- 3007349751
- 3003268355
- 9680746
- 3005174594
- 2245285
- 3005333358
- 2432235
- 3010324880
- 3022178699
- 3012963943
- 2250051
- 2915274
- 2244821
- 8023018
- 3002809144
- 2182595
- 9612316
- 3007118747
- 2020726
- 1222302
- 3009518015
- 2517506
- 2032087
- 3007361513
- 3009092698
- 2122870
- 8031673
- 2032682
- 3011989923
- 3002637618
- 3002642396
- 2032900
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3021841051
- 8021924
- 9615777
- 3000308930
- 3014862385
- 2032839
Source Documents#
Other 510(k) Records For Product Code MRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 |
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | 2023-09-22 |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 2023-01-19 |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021-09-01 |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | 2018-06-22 |
| K172992 | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | 2018-01-11 |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | 2017-03-16 |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | Roche Diagnostics | 2017-02-08 |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | 2017-01-12 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | 2016-11-15 |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Abbott Laboratories | 2016-08-12 |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Fujirebio Diagnostics,Inc. | 2016-04-15 |
| K150270 | 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 | Tosoh Bioscience, Inc. | 2015-10-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary