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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K853054 | RF CARD TEST | Preco, Inc. | 1985-08-01 | Traditional | PDF ↗ |
| K851537 | LASER RF CONTROL SERUM-QUALITY CONTROL SERUM | Behring Diagnostics, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K851099 | IGM RHEUMATOID FACTOR TEST KIT | Breit Laboratories, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850296 | LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS | Behring Diagnostics, Inc. | 1985-04-12 | Traditional | PDF ↗ |
| K850373 | ABBOTT RF EIA DIAGNOSTIC KIT | Abbott Laboratories | 1985-03-01 | Traditional | PDF ↗ |
| K843896 | RHEUMADX LATEX AGGLUTINATION RHEUMATOID | Diagnostic Products Corp. | 1984-10-25 | Traditional | PDF ↗ |
| K841454 | RF TEST KIT | Difco Laboratories, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K841146 | NCS RA LATEX TEST | Ncs Diagnostics, Inc. | 1984-04-20 | Traditional | PDF ↗ |
| K840863 | SERATEST RF LATEX DETERMINATION | Seragen Diagnostics, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K840005 | NABI RF-Q.S. TEST | Intl. Diagnostic, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K840049 | SOPHEIA MP IGM RHEUMATOID FACTOR EIA | Diagnostic Products Corp. | 1984-02-10 | Traditional | PDF ↗ |
| K834391 | IMMUNO-RA | Immunostics Co., Inc. | 1984-02-03 | Traditional | PDF ↗ |
| K831941 | LEAP RHEUMATOID FACTOR TEST KIT | Cooper Diagnostics, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K831597 | SERO/TEX RED CELL RF TEST | Texas Immunology, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K831467 | RA-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K830832 | RHEUMATOID FACTOR-RAPID CARD TEST #65114 | Emd Chemicals, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K830611 | RA SCREENING TEST | Tago, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K822905 | LATEST RF KIT FOR RHEUMATOID FACTOR | Fisher Scientific Co., LLC | 1982-10-18 | Traditional | PDF ↗ |
| K821941 | RHEUMATOID FACTOR REFERENCE PREPARA. | Armkel, LLC | 1982-08-27 | Traditional | PDF ↗ |
| K821319 | SERO/TEX RF TEST | Texas Immunology, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K813309 | RA-80 POSITIVE CONTROL | Sun-Kit | 1981-12-17 | Traditional | PDF ↗ |
| K812968 | FIAX RHEUMATOID FACTOR TEST KIT | Intl. Diagnostic Technology | 1981-11-06 | Traditional | PDF ↗ |
| K812972 | RA LATEX TEST | Oxoid U.S.A., Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812882 | RHEUMATEX | Armkel, LLC | 1981-10-26 | Traditional | PDF ↗ |
| K811375 | BI-RA SLIDE TEST | Biologics Intl., Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K810404 | RHEUMATOID FACTORS REFERENCE SERUM | Calbiochem-Behring Corp. | 1981-03-11 | Traditional | PDF ↗ |
| K810306 | RHEUMATOID FACTOR REAGENT TEST KIT | Beckman Instruments, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K810221 | SCRIPPSERA THEUMATOID FACTOR REFER. CNTL | Scripps-Miles, Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K810141 | SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT | Scripps-Miles, Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K802448 | RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. | Syn-Kit, Inc. | 1981-01-05 | Traditional | PDF ↗ |
| K802688 | RHEUMATOID FACTOR TEST SYSTEMS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-12-18 | Traditional | PDF ↗ |
| K801961 | RF-II TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800268 | AUTOMATED RHEMATOID FACTOR TEST (ARFT) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-02-21 | Traditional | PDF ↗ |
| K792695 | ANTI-GLOBULIN CONTROL | Meridian Diagnostics, Inc. | 1980-01-24 | Traditional | PDF ↗ |
| K792697 | NORMAL GLOBULIN REAGENT | Meridian Diagnostics, Inc. | 1980-01-24 | Traditional | PDF ↗ |
| K791507 | AGGLUTINOTEST-RHEUMATOID ARTHRITIS | Volu Sol Medical Industries | 1979-12-31 | Traditional | PDF ↗ |
| K792061 | CORDIA RF | Cordis Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K790351 | RHEUMATELL | Central Biological Co. | 1979-03-15 | Traditional | PDF ↗ |
| K790012 | RHEUMOGEN TEST SYSTEM | Calbiochem-Behring Corp. | 1979-01-26 | Traditional | PDF ↗ |
| K771940 | QUANTROLS RF | Organon, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771410 | RHEUMANOSTICON R | Organon, Inc. | 1977-09-02 | Traditional | PDF ↗ |
| K771552 | LAS-R RHEUMATOID FACTOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-08-30 | Traditional | PDF ↗ |
| K760043 | TEST, RHEUM. ARTH., CARD (MACRO-VUE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 | Traditional | PDF ↗ |
| K760036 | TEST, LATEX SLIDE, RHEUMATOID FACTOR | Gamma Biologicals, Inc. | 1976-08-03 | Traditional | PDF ↗ |
Product code DHR · Class II · Immunology. Data: openFDA.