Rianen, Vitamin B12 Assay System
FDA 510(k) K792175 · New England Nuclear
510(k) numberK792175
Submission
- Device name
- Rianen, Vitamin B12 Assay System
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- October 29, 1979
- Decision date
- November 13, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDD – Radioassay, Vitamin B12
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2024SE |
| K223289 | Access Vitamin B12CDD · Traditional | Beckman Coulter, Inc. | 12/23/2022SE |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…CDD · Traditional | Beckman Coulter Biomedical GmbH | 10/04/2019SE |
| K192064 | LIAISON Vitamin B12CDD · Traditional | DiaSorin, Inc. | 10/02/2019SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | Axis-Shield Diagnostics, Ltd. | 10/27/2017SE |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12…CDD · Traditional | Diazyme Laboratories | 09/20/2016SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | Axis-Shield Diagnostics Limited | 07/26/2016SE |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetCDD · Traditional | Roche Diagnostics | 09/24/2015SE |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…CDD · Special | Beckman Coulter, Inc. | 09/16/2014SE |
| K133512 | Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)CDD · Traditional | Siemens Healthcare Diagnostics | 01/02/2014SE |
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|---|---|---|
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | 06/14/1984SE |
| K840301 | Rianen Estriol Radioimmunoassay KitCGI · Traditional | 03/30/1984SE |
| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | 12/20/1983SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K790817 | Ria Kit, Quantitation of Prostatic AcidJFH · Traditional | 05/07/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | 09/14/1978SE |
Questions and answers
When was Rianen, Vitamin B12 Assay System cleared by the FDA?
Rianen, Vitamin B12 Assay System (K792175) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 15 days after the submission was received.
What is the product code of K792175?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.