Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DDG · Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
230 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240987 | Access sTfR | Beckman Coulter, Inc. | 2024-07-03 | 84 | 0 |
| K190495 | Transferrin | Biosystems S.A. | 2020-03-16 | 382 | 0 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018-11-05 | 94 | 0 |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2013-02-13 | 384 | 0 |
| K080634 | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WIT | Beckman Coulter, Inc. | 2008-08-11 | 158 | 0 |
| K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION | Siemens Healthcare Diagnostics, Inc. | 2008-08-08 | 92 | 0 |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HI | Thermo Electron OY | 2007-08-08 | 302 | 0 |
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTRO | Good Biotech Corp. | 2007-04-23 | 124 | 0 |
| K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CA | Dade Behring, Inc. | 2007-03-21 | 103 | 0 |
| K063322 | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBR | Dade Behring, Inc. | 2007-01-24 | 82 | 0 |
| K053075 | N ANTISERA TO HUMAN TRANSFERRIN | Dade Behring, Inc. | 2006-03-16 | 135 | 0 |
| K042477 | VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PR | Ortho-Clinical Diagnostics, Inc. | 2004-11-19 | 67 | 0 |
| K012371 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 | 55 | 0 |
| K012393 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 | 54 | 0 |
| K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTR | The Binding Site, Ltd. | 2001-07-30 | 62 | 0 |
| K003064 | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI | Roche Diagnostics Corp. | 2001-05-01 | 211 | 1 |
| K002585 | RANDOX TRANSFERRIN | Randox Laboratories, Ltd. | 2001-02-05 | 168 | 0 |
| K994294 | DIMENSION TRNF FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-02-04 | 45 | 0 |
| K993537 | K-ASSAY TRANSFERRIN | Kamiya Biomedical Co. | 1999-11-30 | 42 | 0 |
| K993162 | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-12 | 51 | 0 |
| K991157 | N LATEX STFR REAGENT | Dade Behring, Inc. | 1999-08-02 | 117 | 0 |
| K983880 | TRANSFERRIN SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 1998-12-18 | 46 | 0 |
| K983167 | TRF | Abbott Laboratories | 1998-11-04 | 55 | 0 |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Behring Diagnostics, Inc. | 1997-10-17 | 77 | 0 |
| K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT | Beckman Instruments, Inc. | 1997-08-20 | 84 | 0 |
| K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT | Crestat Diagnostics, Inc. | 1997-06-16 | 230 | 0 |
| K963976 | IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT | Beckman Instruments, Inc. | 1997-03-19 | 166 | 0 |
| K963427 | IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT | Beckman Instruments, Inc. | 1996-10-07 | 38 | 0 |
| K933589 | BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY | Boehringer Mannheim Corp. | 1993-11-03 | 100 | 0 |
| K926272 | BECKMAN TRANSFERRIN KIT | Beckman Instruments, Inc. | 1993-10-07 | 293 | 0 |
| K914993 | IL TEST(TM) TRANSFERRIN (TRF) | Instrumentation Laboratory CO | 1992-01-17 | 71 | 0 |
| K914390 | TRANSFERRIN RID KIT | The Binding Site, Ltd. | 1991-12-09 | 69 | 0 |
| K900875 | RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT | Reagents Applications, Inc. | 1990-03-06 | 8 | 0 |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Atlantic Antibodies | 1989-03-03 | 38 | 0 |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | Orion Diagnostica, Inc. | 1988-10-19 | 22 | 0 |
| K873867 | TRANSFERRIN | Unipath , Ltd. | 1987-10-13 | 50 | 0 |
| K873789 | QM300 TRANSFERRIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-10-07 | 20 | 0 |
| K871896 | TINA-QUANT [A] TRANSFERRIN | Boehringer Mannheim Corp. | 1987-06-15 | 31 | 0 |
| K871022 | PRECIMAT(R) TRANSFERRIN | Boehringer Mannheim Corp. | 1987-05-14 | 59 | 0 |
| K854416 | TDX TRANSFERRIN DIAGNOSTIC KIT | Abbott Laboratories | 1986-02-21 | 109 | 0 |
| K851287 | RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN | Cooper Biomedical, Inc. | 1985-05-24 | 53 | 0 |
| K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN | Applications Lab | 1985-03-05 | 20 | 0 |
| K830911 | RADIAL IMMUNODIFFUSION PLATES | Biocell Laboratories, Inc. | 1983-06-10 | 81 | 0 |
| K813288 | NEIA TRANSFERRIN ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-12-17 | 24 | 0 |
| K812492 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN | Dako Corp. | 1981-09-23 | 23 | 0 |
| K811613 | 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST | Kent Laboratories, Inc. | 1981-08-12 | 65 | 0 |
| K801434 | J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS | J.T. Baker Chemical Co. | 1980-07-08 | 20 | 0 |
| K772253 | TRANSFERRIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda