Phase II B-12/FOLATE Kit
FDA 510(k) K853224 · Medical & Scientific Designs, Inc.
510(k) numberK853224
Submission
- Device name
- Phase II B-12/FOLATE Kit
- Applicant
- Medical & Scientific Designs, Inc.
Rockland, MA, US - Received
- August 1, 1985
- Decision date
- October 3, 1985
- 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 |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | 08/27/1986SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | 04/25/1984SE |
| K840328 | Phase II HCG KitJHI · Traditional | 04/19/1984SE |
| K834219 | Phase II Cortisol KitCGR · Traditional | 02/04/1984SE |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | 01/24/1984SE |
| K832499 | Phase II TSH KitJLW · Traditional | 09/12/1983SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K831064 | Phase II T3 Radioimmunoassay KitCDP · Traditional | 05/09/1983SE |
| K830900 | Uptake T3 Radioimmunoassay KitKHQ · Traditional | 04/18/1983SE |
Questions and answers
When was Phase II B-12/FOLATE Kit cleared by the FDA?
Phase II B-12/FOLATE Kit (K853224) received a 510(k) decision of Substantially Equivalent on October 3, 1985, 63 days after the submission was received.
What is the product code of K853224?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.