DSL Ferritin Irma
FDA 510(k) K841925 · Diagnostic Systems Laboratories, Inc.
510(k) numberK841925
Submission
- Device name
- DSL Ferritin Irma
- Applicant
- Diagnostic Systems Laboratories, Inc.
Mchenry, IL, US - Received
- May 10, 1984
- Decision date
- May 25, 1984
- 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 |
|---|---|---|
| K061758 | Active Renin IrmaCIB · Special | 07/28/2006SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | 05/31/2002SE |
| K020128 | Active Free Beta-Hcg Elisa, Model DSL-10-8500JHI · Traditional | 03/01/2002SE |
| K002128 | Active Inhibin-A Elisa, Model DSL-10-28100NDR · Traditional | 12/05/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | 05/18/2000SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | 06/21/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | 05/27/1998SE |
Questions and answers
When was DSL Ferritin Irma cleared by the FDA?
DSL Ferritin Irma (K841925) received a 510(k) decision of Substantially Equivalent on May 25, 1984, 15 days after the submission was received.
What is the product code of K841925?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.