FDA Product Code
FDA Product Code DBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5340
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | 2021-09-14 | Traditional | PDF ↗ |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | 2020-03-06 | Traditional | PDF ↗ |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | Diazyme Laboratories | 2014-06-24 | Traditional | PDF ↗ |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | Kamiya Biomedical Company | 2012-05-24 | Traditional | PDF ↗ |
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 | Traditional | PDF ↗ |
| K100538 | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | 2010-06-22 | Traditional | PDF ↗ |
| K092505 | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006-11-20 | Traditional | PDF ↗ |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | 2006-03-13 | Traditional | PDF ↗ |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Good Biotech Corp. | 2006-02-23 | Traditional | PDF ↗ |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2005-12-23 | Traditional | PDF ↗ |
| K040879 | QUANTEX FERRITIN | Instrumentation Laboratory CO | 2004-05-10 | Traditional | PDF ↗ |
| K031650 | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | 2003-07-17 | Traditional | PDF ↗ |
| K030124 | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | 2003-02-06 | Special | PDF ↗ |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2002-02-19 | Traditional | PDF ↗ |
| K000662 | RANDOX FERRITIN | Randox Laboratories, Ltd. | 2000-04-03 | Traditional | PDF ↗ |
| K993273 | N LATEX FERRITIN | Dade Behring, Inc. | 1999-11-23 | Traditional | PDF ↗ |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Biocheck, Inc. | 1999-09-24 | Traditional | PDF ↗ |
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | 1999-08-05 | Traditional | PDF ↗ |
| K984186 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY | Nichols Institute Diagnostics | 1999-02-02 | Traditional | PDF ↗ |
| K983340 | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR | Beckman Coulter, Inc. | 1998-12-14 | Traditional | PDF ↗ |
| K983759 | ABBOTT ARCHITECT FERRITIN | Abbott Laboratories | 1998-12-07 | Traditional | PDF ↗ |
| K982714 | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY | Bayer Corp. | 1998-10-22 | Traditional | PDF ↗ |
| K974505 | AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 | Alfa Biotech (Uk) , Ltd. | 1998-02-17 | Traditional | PDF ↗ |
| K973331 | VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) | Ortho-Clinical Diagnostics, Inc. | 1997-10-22 | Traditional | PDF ↗ |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Behring Diagnostics, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | Sealite Sciences, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K963170 | OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | United Biotech, Inc. | 1995-07-05 | Traditional | PDF ↗ |
| K952286 | AMERLITE FERRITIN II ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K950707 | N LATEX FERRITIN | Behring Diagnostics, Inc. | 1995-03-27 | Traditional | PDF ↗ |
| K935847 | AXSYM FERRITIN | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K935528 | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH | E.I. Dupont DE Nemours & Co., Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K931576 | VISTA FERRITIN ASSAY | Syva Co. | 1993-08-05 | Traditional | PDF ↗ |
| K924858 | AIA-PACK FER CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-12-15 | Traditional | PDF ↗ |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | Vitek Systems, Inc. | 1992-04-07 | Traditional | PDF ↗ |
| K920046 | MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K911175 | SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-04-05 | Traditional | PDF ↗ |
| K905770 | CIBA CORNING ACS FERRITIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-03-12 | Traditional | PDF ↗ |
| K904822 | ELEGANCE FERRITIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-29 | Traditional | PDF ↗ |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | London Diagnostics, Inc. | 1990-04-02 | Traditional | PDF ↗ |
| K896585 | MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K895872 | LAN.0800Q/2800Q | Amersham Corp. | 1989-10-17 | Traditional | PDF ↗ |
| K892362 | AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) | Amersham Corp. | 1989-05-09 | Traditional | PDF ↗ |
| K885074 | AFFINITY(TM) FERRITIN IMMUNIT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-01-04 | Traditional | PDF ↗ |
| K884683 | FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K883746 | MICROMEDIC FERRITIN IRMA KIT | Icn Micromedic Systems | 1988-10-27 | Traditional | PDF ↗ |
| K874203 | AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 | Amersham Corp. | 1988-01-27 | Traditional | PDF ↗ |
| K874572 | ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1987-12-02 | Traditional | PDF ↗ |
| K874031 | IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 | Diagnostic Products Corp. | 1987-11-25 | Traditional | PDF ↗ |
| K873573 | CIBA CORNING MAGIC LITE FERRITIN | Ciba Corning Diagnostics Corp. | 1987-10-07 | Traditional | PDF ↗ |
| K871489 | DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM | Diagnostic Systems Laboratories, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K870570 | FERRITIN MAB SOLID PHASE COMPONENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-12 | Traditional | PDF ↗ |
| K870107 | COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS | Diagnostic Products Corp. | 1987-02-10 | Traditional | PDF ↗ |
| K864437 | BECKMAN EPSILON(TM) FERRITIN TEST KIT | Beckman Instruments, Inc. | 1987-01-16 | Traditional | PDF ↗ |
| K863345 | TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1986-10-08 | Traditional | PDF ↗ |
| K863487 | QUANTIMUNE(R) FERRITIN IRMA | Bio-Rad | 1986-10-01 | Traditional | PDF ↗ |
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1986-08-27 | Traditional | PDF ↗ |
| K862014 | IMMPULSE FERRITIN ASSAY REAGENT | Sclavo, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K860137 | ENZYMUN-TEST FERRITIN | Boehringer Mannheim Corp. | 1986-03-28 | Traditional | PDF ↗ |
| K844158 | STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1984-11-19 | Traditional | PDF ↗ |
| K841925 | DSL FERRITIN IRMA | Diagnostic Systems Laboratories, Inc. | 1984-05-25 | Traditional | PDF ↗ |
| K830580 | DIAGNON FERRITIN 125 I RIA KIT | Iagnon Corp. | 1983-05-05 | Traditional | PDF ↗ |
| K830591 | CORNING FERRITIN 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | 1983-03-24 | Traditional | PDF ↗ |
| K823871 | TANDEM-E -FER IMMUNOENZYMETRIC KIT | Hybritech, Inc. | 1983-02-25 | Traditional | PDF ↗ |
| K823275 | AUTOPAK FERRITIN TEST DELIVERY SYS | Micromedic Systems | 1982-12-03 | Traditional | PDF ↗ |
| K822472 | ANTISERA TO HUMAN FERRITIN | Kent Laboratories, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K812901 | 125I FERRITIN RADIOIMMUNOASSAY KIT | Bio-Ria | 1981-12-30 | Traditional | PDF ↗ |
| K812786 | FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS | Corning Medical & Scientific | 1981-10-23 | Traditional | PDF ↗ |
| K812597 | FERRITIN KIT | Hybritech, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K812056 | SPECTRO FEIRITIN | Ramco Laboratories, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K811880 | LEECO FERRITIN-QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1981-07-16 | Traditional | PDF ↗ |
| K811804 | FERRITIN RIA KIT | Amersham Corp. | 1981-07-10 | Traditional | PDF ↗ |
| K811808 | AUTOPAK-12 FERRITIN KIT | Micromedic Systems | 1981-07-10 | Traditional | PDF ↗ |
| K801989 | NORDICLAB FERRITIN IRMA TEST | Nordiclab Intl. | 1980-09-16 | Traditional | PDF ↗ |
| K801676 | FERRIZYME FERRITIN ENZYME IMMUNOASSAY | Abbott Laboratories | 1980-08-20 | Traditional | PDF ↗ |
| K801580 | FERRITIN RIA KIT | Diagnostic Products Corp. | 1980-08-13 | Traditional | PDF ↗ |
| K800657 | FERRITIN CONTROLS CODE QAS.104 | Amersham Corp. | 1980-04-16 | Traditional | PDF ↗ |
| K800299 | FERRITIN RIA KIT | Amersham Corp. | 1980-03-03 | Traditional | PDF ↗ |
| K792449 | CENTRIA FERRITIN RIA | Union Carbide Corp. | 1979-12-31 | Traditional | PDF ↗ |
| K792442 | FERRITIN RADIOIMMUNOASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-12-18 | Traditional | PDF ↗ |
| K791860 | FERRITIN RIA KIT | Cis Radiopharmaceuticals, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K790447 | VENTRE/SEP FERRITIN RIA | Ventrex Laboratories, Inc. | 1979-04-23 | Traditional | PDF ↗ |
| K790490 | NEIA-FERRITIN ENZYMEIMMUNASSAY KIT | New England Immunology Assoc. | 1979-04-23 | Traditional | PDF ↗ |
| K780490 | NEIA-FERRITIN ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1978-04-10 | Traditional | PDF ↗ |
| K770702 | IN VITRO FERRITIN RIA TEST | Clinical Assays, Inc. | 1977-06-17 | Traditional | PDF ↗ |
Product code DBF · Class II · Immunology. Data: openFDA.