DEW — Igg, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DEW
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K050113 | roche diagnostics | TINA-QUANT IGG GEN.2 | February 8, 2005 |
| K040434 | roche diagnostics | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | March 10, 2004 |
| K010617 | helena laboratories | SPIFE IFE CALIBRATOR AND CONTROL KIT | March 15, 2001 |
| K993928 | wako chemicals usa | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | January 18, 2000 |
| K993281 | kamiya biomedical | K-ASSAY IGG | November 9, 1999 |
| K983221 | abbott laboratories | IGG | November 4, 1998 |
| K963974 | beckman instruments | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | March 6, 1997 |
| K965108 | beckman instruments | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | March 6, 1997 |
| K963868 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | February 10, 1997 |
| K962202 | instrumentation laboratory | QUANTEX IGG | September 26, 1996 |
| K955798 | randox laboratories | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | April 5, 1996 |
| K951635 | beckman instruments | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRA | May 15, 1995 |
| K943997 | behring diagnostics | BEHRING NEPHELOMETER II | October 3, 1994 |
| K934324 | organon teknika | OT IGG SORBENT | April 21, 1994 |
| K933314 | bio-rad | RADIAS FERRITIN ENZYME IMMUNOASSAY | September 8, 1993 |
| K924197 | zeus scientific | ZORBA(TM) IGG REMOVAL REAGENT | December 15, 1992 |
| K921575 | virotech diagnostika | IGG SUCLASS EIA | May 28, 1992 |
| K911610 | janssen research foundation | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | June 12, 1991 |
| K900943 | technicon instruments | MODIFIED TECHNICON DPA-1(TM) SYSTEM | April 26, 1990 |
| K893419 | coulter immunology | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | August 3, 1989 |