Panels › Immunology › Product code DGC · Class 2
Ige, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (114 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DGC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 16 | 0 |
| Ventrex Laboratories, Inc. | 12 | 0 |
| Kallestad Laboratories, Inc. | 8 | 0 |
| Diagnostic Products Corp. | 6 | 0 |
| Hybritech, Inc. | 4 | 0 |
| Allergenetics | 3 | 0 |
| Mast Immunosystems | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| 3M Company | 2 | 0 |
| Abbott Laboratories | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 1987 | K874406 | IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 Medix Biotech, Inc. | DGC |
| Sep 10, 1987 | K872913 | ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 Diagnostic Products Corp. | DGC |
| Aug 28, 1987 | K872968 | ULTRASCAN IGE ASSAY KIT Specialty Medical Industries, Inc. | DGC |
| Dec 3, 1986 | K864142 | UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE United Biotech, Inc. | DGC |
| Nov 3, 1986 | K863858 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- Hybritech, Inc. | DGC |
| Oct 29, 1986 | K863822 | ENZYMUN-TEST(R) IGE Boehringer Mannheim Corp. | DGC |
| Aug 6, 1986 | K862174 | TIMOTHY ALLERGEN DISC Immuno Nuclear Corp. | DGC |
| Jul 3, 1986 | K862368 | AMPLIFIED ELISA IGE KIT Allertec, Inc. | DGC |
| Apr 25, 1986 | K861171 | QUIDEL ALLERGY SCREEN Quidel Corp. | DGC |
| Apr 11, 1986 | K860032 | TOTAL IGE-IRMA RIA KIT Diagnostic Products Corp. | DGC |
| Apr 7, 1986 | K860033 | EIA MONOCLONAL TOTAL IGE KIT Diagnostic Products Corp. | DGC |
| Aug 28, 1985 | K852878 | THE DPC MONOCLONAL EIA TOTAL IGE KIT Diagnostic Products Corp. | DGC |
| Aug 22, 1985 | K853025 | IMAGE-IGE Clinical Reference Laboratory, Inc. | DGC |
| Jul 10, 1985 | K852268 | QUANTICLONE IGE RADIOIMMUNASSAY Kallestad Laboratories, Inc. | DGC |
| Apr 25, 1985 | K851156 | PHARMACIA IGE RIA MODIFIED Pharmacia, Inc. | DGC |
| Apr 12, 1985 | K850786 | TOTAL HIGE ENZYME IMMUNOASSAY Nms Pharmaceuticals, Inc. | DGC |
| Nov 14, 1984 | K843369 | AGGLUTINATION TEST FOR TOTAL IGE Scientific Research | DGC |
| Oct 22, 1984 | K843710 | ELISA FOR TOTAL IGE Scientific Research | DGC |
| Oct 1, 1984 | K843408 | ENCORE IGE REAGENT Hybritech, Inc. | DGC |
| Jun 7, 1984 | K842125 | ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. | DGC |
| Jun 7, 1984 | K841829 | PHADEBAS RAST PHADEZYM RAST ALLERGEN Pharmacia, Inc. | DGC |
| Jun 7, 1984 | K841824 | PHARMACIA IGE RIA Pharmacia, Inc. | DGC |
| Jun 7, 1984 | K841642 | MAST LUMINESCENT ALLERGY SYS Mast Immunosystems | DGC |
| Jun 1, 1984 | K841651 | VAST VENTREX RAST ALL Ventrex Laboratories, Inc. | DGC |
| May 21, 1984 | K840476 | PHADEXACT SERUM, TOTAL IGE CONTROLS Pharmacia, Inc. | DGC |
| Apr 4, 1984 | K840674 | SENSIBEAD EIA IGE KIT Terumo Medical Corp. | DGC |
| Mar 23, 1984 | K840538 | PHADEXACT SERUM, ALLERGEN SPECIFIC IGE Pharmacia, Inc. | DGC |
| Feb 10, 1984 | K834594 | TOTAL IGE FAST TEST Allergenetics | DGC |
| Feb 3, 1984 | K833419 | LABELED 125I ANTI-IGE Allergenetics | DGC |
| Jan 4, 1984 | K833969 | MAST TOTAL IGE Mast Immunosystems | DGC |
| Nov 25, 1983 | K832345 | POLYSTYRENE MICROTITER WELL IMMUNOSOR Diagnostic Reagent Tech. | DGC |
| Oct 14, 1983 | K832360 | ABBOTT IGE EIA Abbott Laboratories | DGC |
| Sep 20, 1983 | K832218 | ALLERGEN CONTROL INHALENT Ventrex Laboratories, Inc. | DGC |
| Jun 2, 1983 | K831485 | VENTRE/ZYME IGE KIT Ventrex Laboratories, Inc. | DGC |
| Jun 2, 1983 | K831377 | IGE RADIOIMMUNOASSAY KIT American Diagnostic Corp. | DGC |
| Jun 2, 1983 | K831326 | ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. | DGC |
| May 9, 1983 | K831208 | IGE-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. | DGC |
| Apr 27, 1983 | K830817 | NEW ALLERGEN DISCS FOR USE IN VAST VENT Ventrex Laboratories, Inc. | DGC |
| Mar 17, 1983 | K830357 | RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E Clinetics Corp. | DGC |
| Mar 1, 1983 | K830164 | DENSITOMETRIC INHALENT PROFILE SLLER Mast Immunosystems | DGC |
| Jan 14, 1983 | K823494 | TOTAL IGE-FAST TEST Axonics, Inc. | DGC |
| Jan 12, 1983 | K823842 | PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. | DGC |
| Jan 12, 1983 | K823841 | PHADEBAS RAST ALLERGEN DISCS Pharmacia, Inc. | DGC |
| Dec 28, 1982 | K823507 | TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY Hybritech, Inc. | DGC |
| Dec 15, 1982 | K823403 | ALLERCOAT POSITIVE CONTROL SERUM Kallestad Laboratories, Inc. | DGC |
| Nov 10, 1982 | K822341 | ALLERGENETICS IGE-FAST TEST Allergenetics | DGC |
| Oct 22, 1982 | K822613 | RAST ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. | DGC |
| Sep 2, 1982 | K822442 | VAST VENTREX RAST ALLERGEN DISCS Ventrex Laboratories, Inc. | DGC |
| Aug 16, 1982 | K822206 | TOTAL IGE DISCS Kallestad Laboratories, Inc. | DGC |
| Jun 22, 1982 | K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT Clinical Assays, Inc. | DGC |
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