FDA 510(k) Applications for Medical Device Product Code "DGC"
(Ige, Antigen, Antiserum, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K034057 | ADIATEC SA | LACRYTEST | 03/09/2004 |
| K024210 | BECKMAN COULTER, INC. | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | 02/24/2003 |
| K220178 | Beckman Coulter, Inc. | Total Immunoglobulin E (IgE) | 03/23/2022 |
| K992528 | BIOCHECK, INC. | BIOCHECK IGE ELISA, MODEL BC-1035 | 09/21/1999 |
| K050493 | BIOKIT S.A. | QUANTIA IGE | 08/16/2005 |
| K214068 | Biokit, S.A. | Quantia IgE | 02/21/2023 |
| K983185 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | 11/12/1998 |
| K063425 | DADE BEHRING, INC. | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | 02/15/2007 |
| K991787 | DADE BEHRING, INC. | N LATEX IGE MONO REAGENT | 07/07/1999 |
| K032251 | IMMUNETECH CORPORATION | IMMUNETECH TOTAL IGE SYSTEM | 12/19/2003 |
| K042241 | KAMIYA BIOMEDICAL CO. | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | 12/10/2004 |
| K161899 | PHADIA AB | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve C | 07/28/2016 |
| K133404 | PHADIA AB | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | 02/24/2014 |
| K991945 | PHARMACIA & UPJOHN CO. | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | 07/28/1999 |
| K964152 | PHARMACIA, INC. | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | 04/23/1997 |
| K010855 | RANDOX LABORATORIES, LTD. | RANDOX IGE | 05/15/2001 |
| K193493 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur Total IgE (tIgE) | 01/15/2020 |
| K002560 | THE BINDING SITE, LTD. | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | 10/26/2000 |
| K972697 | TOSOH MEDICS, INC. | AIA-PACK IGE II ASSAY | 10/03/1997 |
| K991316 | TOUCH SCIENTIFIC, INC. | TOUCH TEAR IGE MICROASSAY KIT | 08/09/1999 |
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