FDA Product Code
FDA Product Code DDG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5880
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240987 | Access sTfR | Beckman Coulter, Inc. | 2024-07-03 | Traditional | PDF ↗ |
| K190495 | Transferrin | Biosystems S.A. | 2020-03-16 | Traditional | PDF ↗ |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018-11-05 | Traditional | PDF ↗ |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2013-02-13 | Traditional | PDF ↗ |
| K080634 | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 | Beckman Coulter, Inc. | 2008-08-11 | Traditional | PDF ↗ |
| K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | Thermo Electron OY | 2007-08-08 | Traditional | PDF ↗ |
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C | Good Biotech Corp. | 2007-04-23 | Traditional | PDF ↗ |
| K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H | Dade Behring, Inc. | 2007-03-21 | Traditional | PDF ↗ |
| K063322 | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H | Dade Behring, Inc. | 2007-01-24 | Traditional | PDF ↗ |
| K053075 | N ANTISERA TO HUMAN TRANSFERRIN | Dade Behring, Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K042477 | VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN | Ortho-Clinical Diagnostics, Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K012371 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 | Traditional | PDF ↗ |
| K012393 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 | Traditional | PDF ↗ |
| K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL | The Binding Site, Ltd. | 2001-07-30 | Traditional | PDF ↗ |
| K003064 | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 | Roche Diagnostics Corp. | 2001-05-01 | Traditional | PDF ↗ |
| K002585 | RANDOX TRANSFERRIN | Randox Laboratories, Ltd. | 2001-02-05 | Traditional | PDF ↗ |
| K994294 | DIMENSION TRNF FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K993537 | K-ASSAY TRANSFERRIN | Kamiya Biomedical Co. | 1999-11-30 | Traditional | PDF ↗ |
| K993162 | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-12 | Traditional | PDF ↗ |
| K991157 | N LATEX STFR REAGENT | Dade Behring, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K983880 | TRANSFERRIN SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K983167 | TRF | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Behring Diagnostics, Inc. | 1997-10-17 | Traditional | PDF ↗ |
| K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT | Beckman Instruments, Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT | Crestat Diagnostics, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K963976 | IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT | Beckman Instruments, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K963427 | IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT | Beckman Instruments, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K933589 | BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY | Boehringer Mannheim Corp. | 1993-11-03 | Traditional | PDF ↗ |
| K926272 | BECKMAN TRANSFERRIN KIT | Beckman Instruments, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K914993 | IL TEST(TM) TRANSFERRIN (TRF) | Instrumentation Laboratory CO | 1992-01-17 | Traditional | PDF ↗ |
| K914390 | TRANSFERRIN RID KIT | The Binding Site, Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K900875 | RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT | Reagents Applications, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Atlantic Antibodies | 1989-03-03 | Traditional | PDF ↗ |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | Orion Diagnostica, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K873867 | TRANSFERRIN | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K873789 | QM300 TRANSFERRIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K871896 | TINA-QUANT [A] TRANSFERRIN | Boehringer Mannheim Corp. | 1987-06-15 | Traditional | PDF ↗ |
| K871022 | PRECIMAT(R) TRANSFERRIN | Boehringer Mannheim Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K854416 | TDX TRANSFERRIN DIAGNOSTIC KIT | Abbott Laboratories | 1986-02-21 | Traditional | PDF ↗ |
| K851287 | RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN | Cooper Biomedical, Inc. | 1985-05-24 | Traditional | PDF ↗ |
| K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN | Applications Lab | 1985-03-05 | Traditional | PDF ↗ |
| K830911 | RADIAL IMMUNODIFFUSION PLATES | Biocell Laboratories, Inc. | 1983-06-10 | Traditional | PDF ↗ |
| K813288 | NEIA TRANSFERRIN ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-12-17 | Traditional | PDF ↗ |
| K812492 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K811613 | 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST | Kent Laboratories, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K801434 | J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS | J.T. Baker Chemical Co. | 1980-07-08 | Traditional | PDF ↗ |
| K772253 | TRANSFERRIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
Product code DDG · Class II · Immunology. Data: openFDA.