DDG — Transferrin, Antigen, Antiserum, Control Class II
FDA product code DDG covers "Transferrin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5880. 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
- DDG
- Device Class
- Class II
- Regulation Number
- 866.5880
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240987 | beckman coulter | Access sTfR | July 3, 2024 |
| K190495 | biosystems | Transferrin | March 16, 2020 |
| K182095 | roche diagnostics operations (rdo) | Tina-quant Transferrin ver.2 (urine application) | November 5, 2018 |
| K120236 | binding site group | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | February 13, 2013 |
| K080634 | beckman coulter | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 | August 11, 2008 |
| K081299 | siemens healthcare diagnostics | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI | August 8, 2008 |
| K063086 | thermo electron | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | August 8, 2007 |
| K063766 | good biotech | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- | April 23, 2007 |
| K063663 | dade behring | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL | March 21, 2007 |
| K063322 | dade behring | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR | January 24, 2007 |
| K053075 | dade behring | N ANTISERA TO HUMAN TRANSFERRIN | March 16, 2006 |
| K042477 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KI | November 19, 2004 |
| K012371 | roche diagnostics | TINA-QUANT TRANSFERRIN VER.2 | September 19, 2001 |
| K012393 | roche diagnostics | TINA-QUANT TRANSFERRIN VER.2 | September 19, 2001 |
| K011662 | binding site | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL | July 30, 2001 |
| K003064 | roche diagnostics | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; | May 1, 2001 |
| K002585 | randox laboratories | RANDOX TRANSFERRIN | February 5, 2001 |
| K994294 | dade behring | DIMENSION TRNF FLEX REAGENT CARTRIDGE | February 4, 2000 |
| K993537 | kamiya biomedical | K-ASSAY TRANSFERRIN | November 30, 1999 |
| K993162 | wako chemicals usa | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR | November 12, 1999 |