In Vitro Ferritin Ria Test
FDA 510(k) K770702 · Clinical Assays, Inc.
510(k) numberK770702
Submission
- Device name
- In Vitro Ferritin Ria Test
- Applicant
- Clinical Assays, Inc.
Mchenry, IL, US - Received
- April 18, 1977
- Decision date
- June 17, 1977
- 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 |
|---|---|---|
| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
| K832711 | Vitamin B12 Folate CA-1515-125CDD · Traditional | 10/04/1983SE |
| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | 06/22/1982SE |
| K812227 | Gammacoat (125) Insulin RadioimmunoassayCFP · Traditional | 09/24/1981SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
Questions and answers
When was In Vitro Ferritin Ria Test cleared by the FDA?
In Vitro Ferritin Ria Test (K770702) received a 510(k) decision of Substantially Equivalent on June 17, 1977, 60 days after the submission was received.
What is the product code of K770702?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.