Panels › Immunology › Product code DEW · Class 2
Igg, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (76 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in DEW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 2005 | K050113 | TINA-QUANT IGG GEN.2 Roche Diagnostics Corp. | DEW |
| Mar 10, 2004 | K040434 | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 Roche Diagnostics Corp. | DEW |
| Mar 15, 2001 | K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT Helena Laboratories | DEW |
| Jan 18, 2000 | K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD Wako Chemicals USA, Inc. | DEW |
| Nov 9, 1999 | K993281 | K-ASSAY IGG Kamiya Biomedical Co. | DEW |
| Nov 4, 1998 | K983221 | IGG Abbott Laboratories | DEW |
| Mar 6, 1997 | K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT Beckman Instruments, Inc. | DEW |
| Mar 6, 1997 | K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN Beckman Instruments, Inc. | DEW |
| Feb 10, 1997 | K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) Beckman Instruments, Inc. | DEW |
| Sep 26, 1996 | K962202 | QUANTEX IGG Instrumentation Laboratory CO | DEW |
| Apr 5, 1996 | K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd., IE | DEW |
| May 15, 1995 | K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL Beckman Instruments, Inc. | DEW |
| Oct 3, 1994 | K943997 | BEHRING NEPHELOMETER II Behring Diagnostics, Inc. | DEW |
| Apr 21, 1994 | K934324 | OT IGG SORBENT Organon Teknika Corp. | DEW |
| Sep 8, 1993 | K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY Bio-Rad | DEW |
| Dec 15, 1992 | K924197 | ZORBA(TM) IGG REMOVAL REAGENT Zeus Scientific, Inc. | DEW |
| May 28, 1992 | K921575 | IGG SUCLASS EIA Virotech Diagnostika | DEW |
| Jun 12, 1991 | K911610 | ELISA COMBI-KIT HUMAN IGG SUBCLASSES Janssen Research Foundation | DEW |
| Apr 26, 1990 | K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. | DEW |
| Aug 3, 1989 | K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) Coulter Immunology | DEW |
| Apr 18, 1989 | K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) Vitek Systems, Inc. | DEW |
| Feb 22, 1989 | K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG Atlantic Antibodies | DEW |
| Jul 12, 1988 | K882369 | ACCRAASSAY RID KITS Icn Immunobiologicals | DEW |
| Jul 8, 1988 | K882083 | QM300 IGG ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEW |
| Jun 6, 1988 | K880784 | WAKO(TM) IGG-HA DIRECT Wako Chemicals USA, Inc. | DEW |
| Feb 17, 1988 | K875254 | GULLSORB IGG INACTIVATION REAGENT Gull Laboratories, Inc. | DEW |
| Feb 10, 1988 | K875356 | IMMUNOGLOBULIN G & G SUBCLASSES Birmingham | DEW |
| Oct 13, 1987 | K873870 | IMMUNOGLOBULINS G Unipath , Ltd., GB | DEW |
| Aug 12, 1987 | K872800 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT Abbott Laboratories | DEW |
| Apr 22, 1987 | K871352 | PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS Helena Laboratories | DEW |
| Apr 22, 1987 | K871340 | QM300 IGG ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEW |
| Sep 3, 1986 | K862764 | TINA-QUANT(R) IGG Boehringer Mannheim Corp. | DEW |
| Aug 25, 1986 | K861059 | DAKO ITA SYSTEM Dako Corp. | DEW |
| Sep 16, 1985 | K853465 | GILFORD IMMUNOGLOBULIN G REAGENT Gilford | DEW |
| Jul 15, 1985 | K852589 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT Abbott Laboratories | DEW |
| Jul 15, 1985 | K851541 | DART IMMUNOGLOBULINS REAGENT SYSTEM Coulter Electronics, Inc. | DEW |
| Mar 1, 1985 | K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G Applications Lab | DEW |
| Aug 2, 1984 | K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 Bartels Immunodiagnostic Supplies, Inc. | DEW |
| Jun 22, 1984 | K841816 | OPTIMATE IGG TEST Miles Laboratories, Inc. | DEW |
| Jan 24, 1984 | K833402 | TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN Technicon Instruments Corp. | DEW |
| Oct 31, 1983 | K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC Gelco Diagnostics, Inc. | DEW |
| Oct 28, 1983 | K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN Gelco Diagnostics, Inc. | DEW |
| Apr 27, 1983 | K831101 | TIA-IGG REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | DEW |
| Mar 24, 1983 | K830594 | TITAN IMMUNO-FIX Helena Laboratories | DEW |
| Apr 29, 1982 | K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED Microbiological Research Corp. | DEW |
| Feb 10, 1982 | K812484 | DAKO PAP KIT K505 Dako Corp. | DEW |
| Oct 2, 1981 | K812664 | ACA IMMUNOGLOBULIN G ANALYTICAL TEST E.I. Dupont DE Nemours & Co., Inc. | DEW |
| Sep 29, 1981 | K812630 | ACA IMMUNOGLOBULIN G CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DEW |
| Sep 23, 1981 | K812495 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA Dako Corp. | DEW |
| Sep 23, 1981 | K812489 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG Dako Corp. | DEW |
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