Combostat - No-Boil Kit
FDA 510(k) K801578 · Ria Products, Inc.
510(k) numberK801578
Submission
- Device name
- Combostat - No-Boil Kit
- Applicant
- Ria Products, Inc.
Mchenry, IL, US - Received
- July 9, 1980
- Decision date
- October 23, 1980
- 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 |
|---|---|---|
| K813310 | No-Hoil Combostat II KitCDD · Traditional | 12/17/1981SE |
| K802969 | Cortisol 125-I Radioimmunoassay KitCGR · Traditional | 01/02/1981SE |
| K801579 | Vitamin B12 - No-Boil KitCDD · Traditional | 10/23/1980SE |
| K800710 | Ferritiron Kit Cat. #RP-1100JQG · Traditional | 05/14/1980SE |
| K800914 | No-Boil Folate Kit #RP-500CGN · Traditional | 05/08/1980SE |
| K781844 | Ferritin KitJMG · Traditional | 01/10/1979SE |
| K781769 | Iron 59 KitJJA · Traditional | 12/04/1978SE |
| K780148 | Ria for Folates & Vit. B12, Combo KitCGN · Traditional | 03/03/1978SE |
Questions and answers
When was Combostat - No-Boil Kit cleared by the FDA?
Combostat - No-Boil Kit (K801578) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 106 days after the submission was received.
What is the product code of K801578?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.