FDA Product Code
FDA Product Code DHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5775
510(k) Clearances — 144 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | 2020-05-20 | Traditional | PDF ↗ |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018-12-18 | Traditional | PDF ↗ |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | 2017-05-03 | Traditional | PDF ↗ |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2016-12-07 | Traditional | PDF ↗ |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Immco Diagnostics, Inc. | 2015-09-23 | Traditional | PDF ↗ |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2011-09-30 | Traditional | PDF ↗ |
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | Orgentec Diagnostika GmbH | 2010-10-27 | Traditional | PDF ↗ |
| K083080 | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | Sqi Diagnostics Systems | 2009-10-29 | Traditional | PDF ↗ |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | 2007-08-08 | Traditional | PDF ↗ |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Olympus America, Inc. | 2006-06-06 | Traditional | PDF ↗ |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | The Binding Site | 2004-11-05 | Traditional | PDF ↗ |
| K041863 | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 | Traditional | PDF ↗ |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | Zeus Scientific, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K032535 | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | 2003-09-10 | Special | PDF ↗ |
| K024067 | RHEUMATOID FACTOR (RF) | Abbott Laboratories | 2003-01-15 | Traditional | PDF ↗ |
| K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | Wako Chemicals USA, Inc. | 2002-09-09 | Traditional | PDF ↗ |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Diamedix Corp. | 2002-07-09 | Traditional | PDF ↗ |
| K002609 | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | 2000-09-05 | Traditional | PDF ↗ |
| K000534 | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | Roche Diagnostics Corp. | 2000-04-05 | Traditional | PDF ↗ |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Cogent Diagnotics , Ltd. | 2000-03-03 | Traditional | PDF ↗ |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Cogent Diagnotics , Ltd. | 2000-02-03 | Traditional | PDF ↗ |
| K993843 | MDI RF TEST | Micro Detect, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Cogent Diagnotics , Ltd. | 1999-12-06 | Traditional | PDF ↗ |
| K991467 | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | Kamiya Biomedical Co. | 1999-06-10 | Traditional | PDF ↗ |
| K991409 | K-ASSAY RHEUMATOID FACTOR | Kamiya Biomedical Co. | 1999-06-09 | Traditional | PDF ↗ |
| K990587 | ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 | Bio-Rad | 1999-04-07 | Traditional | PDF ↗ |
| K990035 | RF | Abbott Laboratories | 1999-03-08 | Traditional | PDF ↗ |
| K984045 | RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS | Kamiya Biomedical Co. | 1999-01-25 | Traditional | PDF ↗ |
| K983418 | THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983083 | QUANTA LITE RF IGG ELISA | Inova Diagnostics, Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K983084 | QUANTA LITE RF IGA ELISA | Inova Diagnostics, Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K981496 | COLOR-SLIDE RF | Seradyn, Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K974889 | DIAMEDIX IS-RF TEST SYSTEM | Diamedix Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K974370 | RAPET RF | Stanbio Laboratory | 1998-02-17 | Traditional | PDF ↗ |
| K972456 | RHEUMACOL RHEUMATOID FACTOR TEST | Immunostics Inc., | 1997-11-25 | Traditional | PDF ↗ |
| K973464 | QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) | Instrumentation Laboratory CO | 1997-10-22 | Traditional | PDF ↗ |
| K972220 | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT | Randox Laboratories, Ltd. | 1997-09-09 | Traditional | PDF ↗ |
| K971602 | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT | Beckman Instruments, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K971614 | QUANTA LITE RF IGM | Inova Diagnostics, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K971379 | TINAQUANT RHEUMATOID FACTOR ASSAY | Boehringer Mannheim Corp. | 1997-06-17 | Traditional | PDF ↗ |
| K971788 | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR | Beckman Instruments, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K970373 | RAICHEM RHEUMATOID FACTOR SPIA | Henage Diagnostics, Inc. | 1997-04-17 | Traditional | PDF ↗ |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962050 | THERATEST EL-RFSCR | Theratest Laboratories, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964418 | N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET | Kamiya Technology Services | 1996-12-13 | Traditional | PDF ↗ |
| K964415 | N-ASSAY TIA RHEUMATOID FACTOR TEST KIT | Kamiya Technology Services | 1996-12-13 | Traditional | PDF ↗ |
| K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | Teco Diagnostics | 1996-11-25 | Traditional | PDF ↗ |
| K963048 | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT | Beckman Instruments, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K961545 | QUALITROL RF CONTROLS | Consolidated Technologies, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K962836 | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K961169 | RHEUMATOID FACTOR LATEX SLIDE TEST KIT | Randox Laboratories, Ltd. | 1996-06-26 | Traditional | PDF ↗ |
| K960987 | LIQUICHEK RHEUMATOID FACTOR CONTROL | Bio-Rad | 1996-06-04 | Traditional | PDF ↗ |
| K961277 | RF IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1996-05-08 | Traditional | PDF ↗ |
| K960703 | RF-LATEX SEIKEN REAGENT SYSTEM | Globe Management Support, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K954892 | HYTEC AUTOMIMMUNE KIT (RF) | Hycor Biomedical, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K955086 | TEST, RHEUMATOID FACTOR | Polymedco, Inc. | 1995-12-20 | Traditional | PDF ↗ |
| K953520 | OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K953261 | CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM | Shared Systems, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K941398 | EL-RF/3 (IGM-IGG-IGA) KIT | Theratest Laboratories, Inc. | 1995-07-28 | Traditional | PDF ↗ |
| K942908 | IGM RF EIA | Sigma Diagnostics, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K942328 | N LATEX RF | Behring Diagnostics, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K942272 | IGM RHEUMATOID FACTOR | Immco Diagnostics, Inc. | 1994-09-26 | Traditional | PDF ↗ |
| K933712 | EL-RF TEST SYSTEM: EL-RF-IGM KIT | Theratest Laboratories, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K932437 | EYE SPOT RF TEST | J & S Medical Assoc., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K926569 | IMMUNO RA UNDILUTED | Immunostics Co., Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K915320 | RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST | Trinity Laboratories, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | J.S. Medical Assoc. | 1992-12-01 | Traditional | PDF ↗ |
| K923578 | LIQUICHEK RHEUMATOID FACTOR CONTROL | Bio-Rad | 1992-10-06 | Traditional | PDF ↗ |
| K923771 | PULSE RF TEST | Pulse Scientific, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K922725 | TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K924056 | ENCORE RHEUMATOID FACTOR EIA | Clark Laboratories, Inc. | 1992-09-25 | Traditional | PDF ↗ |
| K922151 | WAKO AUTOKIT RF | Wako Chemicals USA, Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K920753 | RF STAT IGM TEST KIT | Biowhittaker Molecular Applications, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K920220 | HEALTHTEST RHEUMATOID FACTOR ASSAY | Akers Research Corp. | 1992-03-13 | Traditional | PDF ↗ |
| K920124 | TURBIQUANT | Behring Diagnostics, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K904310 | RHEUMAGEN RF T-CONTROL | Biokit USA, Inc. | 1991-05-31 | Traditional | PDF ↗ |
| K910539 | RHEUMAJET RF | Biokit USA, Inc. | 1991-04-05 | Traditional | PDF ↗ |
| K904498 | CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST | Biotrax, Inc. | 1990-10-29 | Traditional | PDF ↗ |
| K904105 | V-TREND TARGET RF TEST | Texas Immunology, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K903852 | RAPITEX(R) RF NEW | Behring Diagnostics, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K902462 | MODIFIED QM300 RHEUMATOID FACTOR TEST | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | Biokit USA, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K894574 | TECHNICON DPA-1 SYSTEM RF METHOD | Technicon Instruments Corp. | 1989-08-10 | Traditional | PDF ↗ |
| K892444 | REAADS-RF TEST KIT-QUANTITATIVE | Biosearch Medical Products, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K892445 | REAADS-RF TEST KIT-SEMIQUANTITATIVE | Biosearch Medical Products, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K884180 | TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Unipath , Ltd. | 1989-02-03 | Traditional | PDF ↗ |
| K883538 | QM300 CALIBRATOR E PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K883536 | QM300 RHEUMATOID FACTOR ANTIGEN PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K883355 | UBI MAGIWEL RF-IGM QUANTITATIVE | United Biotech, Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K880164 | RF CARD TEST & RF LIQUID TEST | Ampcor, Inc. | 1988-02-10 | Traditional | PDF ↗ |
| K874151 | RF DIPSTICK TEST KIT | Lipogen, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K873782 | REUMA TEST | Sclavo, Inc. | 1987-11-27 | Traditional | PDF ↗ |
| K873064 | AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT | Amtec Diagnostics International, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | Orion Diagnostica, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K871041 | RF MICROASSAY | Diamedix Corp. | 1987-03-31 | Traditional | PDF ↗ |
| K863238 | READS RF TEST KIT FOR IGM RHEUMATOID FACTOR | Biostar Medical Products, Inc. | 1986-10-08 | Traditional | PDF ↗ |
| K855221 | SERATEST RF (HEMAGGLUTINATION) KIT | Hemagen Diagnostics, Inc. | 1986-04-22 | Traditional | PDF ↗ |
| K854222 | DIESSE RF TEST KIT | Marvic Interpharma, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K854820 | RA 80 EIKEN | Syn-Kit, Inc. | 1986-01-17 | Traditional | PDF ↗ |
Product code DHR · Class II · Immunology. Data: openFDA.