DBF — Ferritin, Antigen, Antiserum, Control Class II
FDA product code DBF covers "Ferritin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5340. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DBF
- Device Class
- Class II
- Regulation Number
- 866.5340
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193650 | diasorin | LIAISON Ferritin | September 14, 2021 |
| K191562 | horiba abx | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact | March 6, 2020 |
| K171642 | siemens healthcare diagnostics | Atellica IM Ferritin Assay | August 31, 2017 |
| K133083 | diazyme laboratories | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTRO | June 24, 2014 |
| K121232 | kamiya biomedical | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | May 24, 2012 |
| K110736 | siemens healthcare diagnostics | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | August 17, 2011 |
| K100538 | roche diagnostics | TINA-QUANT FERRITIN GEN. 4 | June 22, 2010 |
| K092505 | beckman coulter | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | December 11, 2009 |
| K062746 | medicon hellas | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | November 20, 2006 |
| K053211 | reference diagnostics | RDI HSFERRITIN KIT | March 13, 2006 |
| K052617 | good biotech | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; | February 23, 2006 |
| K050944 | kamiya biomedical | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | December 23, 2005 |
| K040879 | instrumentation laboratory | QUANTEX FERRITIN | May 10, 2004 |
| K031650 | roche diagnostics | FERRITIN GENERATION 2 | July 17, 2003 |
| K030124 | olympus america | OLYMPUS FERRITIN REAGENT | February 6, 2003 |
| K014293 | kamiya biomedical | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | February 19, 2002 |
| K000662 | randox laboratories | RANDOX FERRITIN | April 3, 2000 |
| K993273 | dade behring | N LATEX FERRITIN | November 23, 1999 |
| K992517 | biocheck | BIOCHECK FERRITIN ELISA MODEL BC-1025 | September 24, 1999 |
| K992157 | chiron diagnostics | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | August 5, 1999 |