K-Assay Ferritin, K-Assay Ferritin Calibrator Set
FDA 510(k) K014293 · Kamiya Biomedical Co.
510(k) numberK014293
Submission
- Device name
- K-Assay Ferritin, K-Assay Ferritin Calibrator Set
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- December 28, 2001
- Decision date
- February 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
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| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | 05/20/2020SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Ferritin, K-Assay Ferritin Calibrator Set cleared by the FDA?
K-Assay Ferritin, K-Assay Ferritin Calibrator Set (K014293) received a 510(k) decision of Substantially Equivalent on February 19, 2002, 53 days after the submission was received.
What is the product code of K014293?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.