Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators
FDA 510(k) K984321 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK984321
Submission
- Device name
- Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- December 3, 1998
- Decision date
- January 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDD – Radioassay, Vitamin B12
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Specialty
- Clinical Chemistry
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| 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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Questions and answers
When was Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators cleared by the FDA?
Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators (K984321) received a 510(k) decision of Substantially Equivalent on January 22, 1999, 50 days after the submission was received.
What is the product code of K984321?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.