Ferritin Ria Kit
FDA 510(k) K791860 · Cis Radiopharmaceuticals, Inc.
510(k) numberK791860
Submission
- Device name
- Ferritin Ria Kit
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- September 19, 1979
- Decision date
- December 6, 1979
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K792063 | Follicle Stimulating Hormone (FSH) KitCGJ · Traditional | 11/20/1979SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | 11/05/1979SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | 10/30/1979SE |
| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | 07/24/1979SE |
| K790003 | Ria Kit, ProlactinCFT · Traditional | 03/12/1979SE |
| K780982 | Kits, Ria, Myoglobin, Human, MeasurementDDR · Traditional | 06/22/1978SE |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | 10/27/1977SE |
| K760251 | Set, Oral AdministrationLEY · Traditional | 09/15/1976SE |
Questions and answers
When was Ferritin Ria Kit cleared by the FDA?
Ferritin Ria Kit (K791860) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 78 days after the submission was received.
What is the product code of K791860?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.