FDA Product Code
FDA Product Code DEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 76 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050113 | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2005-02-08 | Traditional | PDF ↗ |
| K040434 | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2004-03-10 | Special | PDF ↗ |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | 2001-03-15 | Traditional | PDF ↗ |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K993281 | K-ASSAY IGG | Kamiya Biomedical Co. | 1999-11-09 | Traditional | PDF ↗ |
| K983221 | IGG | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | Beckman Instruments, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K962202 | QUANTEX IGG | Instrumentation Laboratory CO | 1996-09-26 | Traditional | PDF ↗ |
| K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 | Traditional | PDF ↗ |
| K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | Beckman Instruments, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K943997 | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | 1994-04-21 | Traditional | PDF ↗ |
| K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | 1993-09-08 | Traditional | PDF ↗ |
| K924197 | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | 1992-12-15 | Traditional | PDF ↗ |
| K921575 | IGG SUCLASS EIA | Virotech Diagnostika | 1992-05-28 | Traditional | PDF ↗ |
| K911610 | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | Janssen Research Foundation | 1991-06-12 | Traditional | PDF ↗ |
| K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1990-04-26 | Traditional | PDF ↗ |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Coulter Immunology | 1989-08-03 | Traditional | PDF ↗ |
| K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) | Vitek Systems, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Atlantic Antibodies | 1989-02-22 | Traditional | PDF ↗ |
| K882369 | ACCRAASSAY RID KITS | Icn Immunobiologicals | 1988-07-12 | Traditional | PDF ↗ |
| K882083 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880784 | WAKO(TM) IGG-HA DIRECT | Wako Chemicals USA, Inc. | 1988-06-06 | Traditional | PDF ↗ |
| K875254 | GULLSORB IGG INACTIVATION REAGENT | Gull Laboratories, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K875356 | IMMUNOGLOBULIN G & G SUBCLASSES | Birmingham | 1988-02-10 | Traditional | PDF ↗ |
| K873870 | IMMUNOGLOBULINS G | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K872800 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT | Abbott Laboratories | 1987-08-12 | Traditional | PDF ↗ |
| K871340 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K871352 | PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS | Helena Laboratories | 1987-04-22 | Traditional | PDF ↗ |
| K862764 | TINA-QUANT(R) IGG | Boehringer Mannheim Corp. | 1986-09-03 | Traditional | PDF ↗ |
| K861059 | DAKO ITA SYSTEM | Dako Corp. | 1986-08-25 | Traditional | PDF ↗ |
| K853465 | GILFORD IMMUNOGLOBULIN G REAGENT | Gilford | 1985-09-16 | Traditional | PDF ↗ |
| K852589 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT | Abbott Laboratories | 1985-07-15 | Traditional | PDF ↗ |
| K851541 | DART IMMUNOGLOBULINS REAGENT SYSTEM | Coulter Electronics, Inc. | 1985-07-15 | Traditional | PDF ↗ |
| K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G | Applications Lab | 1985-03-01 | Traditional | PDF ↗ |
| K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K841816 | OPTIMATE IGG TEST | Miles Laboratories, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K833402 | TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN | Technicon Instruments Corp. | 1984-01-24 | Traditional | PDF ↗ |
| K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN | Gelco Diagnostics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K831101 | TIA-IGG REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | Traditional | PDF ↗ |
| K830594 | TITAN IMMUNO-FIX | Helena Laboratories | 1983-03-24 | Traditional | PDF ↗ |
| K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED | Microbiological Research Corp. | 1982-04-29 | Traditional | PDF ↗ |
| K812484 | DAKO PAP KIT K505 | Dako Corp. | 1982-02-10 | Traditional | PDF ↗ |
| K812664 | ACA IMMUNOGLOBULIN G ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K812630 | ACA IMMUNOGLOBULIN G CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K812489 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K812453 | SCRIPPSYSTEM IMMUNOGLOBIN RID KIT | Scripps-Miles, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K812495 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K812328 | SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT | Scripps-Miles, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K810694 | PHADEBAS IGG RAST TEST | Pharmacia, Inc. | 1981-07-23 | Traditional | PDF ↗ |
| K811126 | AIM SYSTEM (FOR IGG) | Icl Scientific | 1981-05-08 | Traditional | PDF ↗ |
| K810056 | IMMUNOLOGY CONTROL SERUM | Icl Scientific | 1981-02-09 | Traditional | PDF ↗ |
| K802257 | GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC | Protos Laboratories | 1980-10-31 | Traditional | PDF ↗ |
| K801281 | J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI | J.T. Baker Chemical Co. | 1980-06-20 | Traditional | PDF ↗ |
| K800897 | RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. | Icl Scientific | 1980-05-08 | Traditional | PDF ↗ |
| K800451 | GEMENI IGG ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K800398 | PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT | Diagnostica, Inc. | 1980-03-12 | Traditional | PDF ↗ |
| K800119 | IMMUNOGLOBULIN G REAGENT SYSTEM | Calbiochem-Behring Corp. | 1980-02-05 | Traditional | PDF ↗ |
| K791281 | ANTI-HUMAN IGG SERUM | Diagnostica, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K791403 | LANCER L-INA ANTI-IGG | Sherwood Medical Co. | 1979-10-17 | Traditional | PDF ↗ |
| K791285 | ANTI-HUMAN GLOBULINS | Diagnostica, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K791824 | ANTISERUM TO HUMAN IMMUNOGLOBULINS | Icl Scientific | 1979-10-17 | Traditional | PDF ↗ |
| K790702 | ANTISERUM, HUMAN, IGG H & L CHAIN | Kent Laboratories, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K790704 | ANTISERUM TO HUMAN IGG | Kent Laboratories, Inc. | 1979-04-12 | Traditional | PDF ↗ |
| K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G | Gelman Instrument Co. | 1978-02-03 | Traditional | PDF ↗ |
| K772252 | IMMUNOGLOBULIN G NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K770961 | GOAT ANTISERUM IGG NEPHELOMETRIC | Kallestad Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770669 | RHODAMINE-CONJUGATED ANTISERUM | Kent Laboratories, Inc. | 1977-04-28 | Traditional | PDF ↗ |
| K770597 | DASP TM ANTI-RABBIT | Organon, Inc. | 1977-04-28 | Traditional | PDF ↗ |
| K770668 | FLUORESCEIN CONJUGATED ANTISERUM | Kent Laboratories, Inc. | 1977-04-28 | Traditional | PDF ↗ |
| K761224 | ULTRA LOW LEVEL IMMUNOGLOBULIN G | Intl. Diagnostic Technology | 1977-04-07 | Traditional | PDF ↗ |
| K770484 | FLUOR. CONJUGATED ANTISERUM | Kent Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-19 | Traditional | PDF ↗ |
Product code DEW · Class II · Immunology. Data: openFDA.