Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H,
FDA 510(k) K052617 · Good Biotech Corp.
510(k) numberK052617
Submission
- Device name
- Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H,
- Applicant
- Good Biotech Corp.
Taichung, TW - Received
- September 23, 2005
- Decision date
- February 23, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K063766 | Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#…DDG · Traditional | 04/23/2007SE |
| K050713 | Duet Hs-Crp Lit Assay, Catalog Number: 4010, Duet Hs-Crp Calibrator Set, Catalog Number:…DCN · Traditional | 06/06/2005SE |
| K050576 | Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-HDDZ · Traditional | 04/21/2005SE |
| K022725 | Crpex CRP Controls Level L, M, H; Cat. No.: 3011, 3012, 3013JJX · Traditional | 09/23/2002SE |
| K021757 | Crpex-Br C-Reactive Protein Lit Assay, Crpex-Br CRP Calibrator SetDCN · Traditional | 07/29/2002SE |
| K021882 | Crpex-Hs CRP Calibrator Set, Catalog No: 1510DCN · Traditional | 07/11/2002SE |
| K020603 | Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010DCN · Traditional | 06/13/2002SE |
Questions and answers
When was Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H, cleared by the FDA?
Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H, (K052617) received a 510(k) decision of Substantially Equivalent on February 23, 2006, 153 days after the submission was received.
What is the product code of K052617?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.