DGC — Ige, Antigen, Antiserum, Control Class II
FDA product code DGC covers "Ige, 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
- DGC
- 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 |
|---|---|---|---|
| K231151 | kenota | Kenota 1 Total IgE; Kenota 1 (instrument) | May 31, 2024 |
| K214068 | biokit | Quantia IgE | February 21, 2023 |
| K220178 | beckman coulter | Total Immunoglobulin E (IgE) | March 23, 2022 |
| K193493 | siemens healthcare diagnostics | ADVIA Centaur Total IgE (tIgE) | January 15, 2020 |
| K161899 | phadia | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To | July 28, 2016 |
| K133404 | phadia | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L | February 24, 2014 |
| K063425 | dade behring | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT | February 15, 2007 |
| K050493 | biokit | QUANTIA IGE | August 16, 2005 |
| K042241 | kamiya biomedical | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | December 10, 2004 |
| K034057 | adiatec | LACRYTEST | March 9, 2004 |
| K032251 | immunetech corporation | IMMUNETECH TOTAL IGE SYSTEM | December 19, 2003 |
| K024210 | beckman coulter | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | February 24, 2003 |
| K010855 | randox laboratories | RANDOX IGE | May 15, 2001 |
| K002560 | binding site | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | October 26, 2000 |
| K992528 | biocheck | BIOCHECK IGE ELISA, MODEL BC-1035 | September 21, 1999 |
| K991316 | touch scientific | TOUCH TEAR IGE MICROASSAY KIT | August 9, 1999 |
| K991945 | pharmacia and upjohn | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | July 28, 1999 |
| K991787 | dade behring | N LATEX IGE MONO REAGENT | July 7, 1999 |
| K983185 | boehringer mannheim | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | November 12, 1998 |
| K972697 | tosoh medics | AIA-PACK IGE II ASSAY | October 3, 1997 |