DEW — Igg, Antigen, Antiserum, Control Class II
FDA product code DEW covers "Igg, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |