Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DBF — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
126 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | 2021-09-14 | 624 | 0 |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C | HORIBA ABX SAS | 2020-03-06 | 267 | 0 |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 | 90 | 0 |
| K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIA | Diazyme Laboratories | 2014-06-24 | 267 | 0 |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATO | Kamiya Biomedical Company | 2012-05-24 | 30 | 0 |
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 | 154 | 3 |
| K100538 | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | 2010-06-22 | 117 | 0 |
| K092505 | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | 2009-12-11 | 119 | 0 |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006-11-20 | 67 | 0 |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | 2006-03-13 | 117 | 0 |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SE | Good Biotech Corp. | 2006-02-23 | 153 | 0 |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2005-12-23 | 253 | 0 |
| K040879 | QUANTEX FERRITIN | Instrumentation Laboratory CO | 2004-05-10 | 35 | 0 |
| K031650 | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | 2003-07-17 | 50 | 0 |
| K030124 | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | 2003-02-06 | 23 | 0 |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2002-02-19 | 53 | 0 |
| K000662 | RANDOX FERRITIN | Randox Laboratories, Ltd. | 2000-04-03 | 35 | 0 |
| K993273 | N LATEX FERRITIN | Dade Behring, Inc. | 1999-11-23 | 54 | 0 |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Biocheck, Inc. | 1999-09-24 | 58 | 0 |
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | 1999-08-05 | 41 | 0 |
| K984186 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY | Nichols Institute Diagnostics | 1999-02-02 | 71 | 0 |
| K983340 | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE | Beckman Coulter, Inc. | 1998-12-14 | 82 | 0 |
| K983759 | ABBOTT ARCHITECT FERRITIN | Abbott Laboratories | 1998-12-07 | 42 | 1 |
| K982714 | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY | Bayer Corp. | 1998-10-22 | 79 | 0 |
| K974505 | AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CAL | Alfa Biotech (Uk) , Ltd. | 1998-02-17 | 78 | 0 |
| K973331 | VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM. | Ortho-Clinical Diagnostics, Inc. | 1997-10-22 | 48 | 0 |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Behring Diagnostics, Inc. | 1997-09-12 | 66 | 0 |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | Sealite Sciences, Inc. | 1997-06-24 | 126 | 0 |
| K963170 | OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-12-02 | 110 | 0 |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | United Biotech, Inc. | 1995-07-05 | 68 | 0 |
| K952286 | AMERLITE FERRITIN II ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-06-20 | 35 | 0 |
| K950707 | N LATEX FERRITIN | Behring Diagnostics, Inc. | 1995-03-27 | 40 | 0 |
| K935847 | AXSYM FERRITIN | Abbott Laboratories | 1994-06-21 | 195 | 0 |
| K935528 | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH | E.I. Dupont DE Nemours & Co., Inc. | 1994-01-28 | 73 | 0 |
| K931576 | VISTA FERRITIN ASSAY | Syva Co. | 1993-08-05 | 128 | 0 |
| K924858 | AIA-PACK FER CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-12-15 | 78 | 0 |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | Vitek Systems, Inc. | 1992-04-07 | 41 | 0 |
| K920046 | MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-01-28 | 22 | 0 |
| K911175 | SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-04-05 | 18 | 0 |
| K905770 | CIBA CORNING ACS FERRITIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-03-12 | 75 | 0 |
| K904822 | ELEGANCE FERRITIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-29 | 36 | 0 |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | London Diagnostics, Inc. | 1990-04-02 | 25 | 0 |
| K896585 | MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1989-12-04 | 13 | 0 |
| K895872 | LAN.0800Q/2800Q | Amersham Corp. | 1989-10-17 | 13 | 0 |
| K892362 | AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) | Amersham Corp. | 1989-05-09 | 33 | 0 |
| K885074 | AFFINITY(TM) FERRITIN IMMUNIT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-01-04 | 27 | 0 |
| K884683 | FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1988-12-27 | 49 | 0 |
| K883746 | MICROMEDIC FERRITIN IRMA KIT | Icn Micromedic Systems | 1988-10-27 | 56 | 0 |
| K874203 | AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 | Amersham Corp. | 1988-01-27 | 104 | 0 |
| K874572 | ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1987-12-02 | 27 | 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