Corning Ferritin 125I Radioimmunoassay
FDA 510(k) K830591 · Corning Medical & Scientific
510(k) numberK830591
Submission
- Device name
- Corning Ferritin 125I Radioimmunoassay
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- February 24, 1983
- Decision date
- March 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
Other 510(k)s with product code DBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193650 | LIAISON FerritinDBF · Traditional | DiaSorin, Inc. | 09/14/2021SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | Horiba Abx SAS | 03/06/2020SE |
| K171642 | Atellica IM Ferritin AssayDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/31/2017SE |
| K133083 | Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control SetDBF · Traditional | Diazyme Laboratories | 06/24/2014SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | Kamiya Biomedical Company | 05/24/2012SE |
| K110736 | Advia Chemistry Ferritin (FRT) MethodDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/17/2011SE |
| K100538 | Tina-Quant Ferritin Gen. 4DBF · Traditional | Roche Diagnostics | 06/22/2010SE |
| K092505 | Beckman Coulter Ferritin Reagent, Model: OSR61203DBF · Traditional | Beckman Coulter, Inc. | 12/11/2009SE |
| K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279DBF · Traditional | Medicon Hellas S.A | 11/20/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | Reference Diagnostics, Inc. | 03/13/2006SE |
More from Reference Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875122 | Disposable Sterile Syringe FiltersKET · Traditional | 01/12/1988SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | 07/07/1987SE |
| K872076 | Corning Disposable Roller BottlesKJB · Traditional | 06/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K854024 | Corning Magic Mab HCG RadioimmunoassayJHI · Traditional | 11/26/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | 03/25/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
Questions and answers
When was Corning Ferritin 125I Radioimmunoassay cleared by the FDA?
Corning Ferritin 125I Radioimmunoassay (K830591) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 28 days after the submission was received.
What is the product code of K830591?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.