DDG — Transferrin, Antigen, Antiserum, Control Class II
FDA Device Classification
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 |