Panels › Immunology › Product code DHB · Class 2
System, Test, Radioallergosorbent (Rast) Immunological
Regulation 866.5750
7510(k)s in 12 months (269 all time)
14recalls in 12 months (27 all time)
16recalls that name a 510(k)
Top companies in DHB
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 39 | 0 |
| Diagnostic Products Corp. | 26 | 0 |
| Hycor Biomedical | 24 | 1 |
| Incstar Corp. | 25 | 0 |
| Phadia AB | 16 | 2 |
| Ventrex Laboratories, Inc. | 18 | 0 |
| Siemens Healthcare Diagnostics | 9 | 8 |
| Immuno Nuclear Corp. | 14 | 0 |
| 3M Company | 13 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 11 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2005 | K051218 | MODIFICATION TO: UNICAP SPECIFIC IGE Pharmacia Diagnostics AB | DHB |
| Mar 21, 2003 | K030590 | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) Hitachi Chemical Diagnostics, Inc. | DHB |
| Dec 17, 2002 | K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE Diagnostic Products Corp. | DHB |
| May 30, 2002 | K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS Diagnostic Products Corp. | DHB |
| May 30, 2002 | K021206 | IMMULITE 2000 SPECIFIC ALLERGENS Diagnostic Products Corp. | DHB |
| Apr 17, 2002 | K020387 | MYALLERGYTEST SYSTEM Immunetech Corporation | DHB |
| Oct 19, 2001 | K013135 | IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) Diagnostic Products Corp. | DHB |
| Oct 15, 2001 | K013134 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) Diagnostic Products Corp. | DHB |
| Feb 18, 2000 | K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 Pharmacia & Upjohn Co. | DHB |
| Dec 1, 1999 | K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F Pharmacia & Upjohn Co. | DHB |
| May 14, 1999 | K991048 | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 Pharmacia & Upjohn Co. | DHB |
| Dec 17, 1998 | K983954 | ALASTAT MICROPLATE MIXED ALLERGEN PANELS Diagnostic Products Corp. | DHB |
| Sep 15, 1998 | K982343 | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 Pharmacia & Upjohn Co. | DHB |
| Feb 9, 1998 | K974580 | ALLERGEN IMMUNOCAP F256,F245,F207,F202 Pharmacia & Upjohn Co. | DHB |
| Feb 9, 1998 | K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 Pharmacia, Inc. | DHB |
| Sep 29, 1997 | K973186 | IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE Diagnostic Products Corp. | DHB |
| Sep 4, 1997 | K972364 | UNICAP PHADIATOP Pharmacia, Inc. | DHB |
| Jul 3, 1997 | K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 Pharmacia, Inc. | DHB |
| May 21, 1997 | K965094 | HYCOR ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
| Dec 23, 1996 | K962976 | PHARMACIA CAP SYSTEM RAST FEIA Pharmacia & Upjohn Co. | DHB |
| Nov 18, 1996 | K963245 | IMMULITE LATEX-SPECIFIC IGE Diagnostic Products Corp. | DHB |
| Oct 10, 1996 | K961889 | SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS Diagnostic Products Corp. | DHB |
| Sep 12, 1996 | K962274 | UNICAP 100 Pharmacia, Inc. | DHB |
| Jan 30, 1996 | K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA Pharmacia, Inc. | DHB |
| Dec 18, 1995 | K954566 | SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM Diagnostic Products Corp. | DHB |
| Nov 14, 1995 | K953780 | ACCESS ALLERGEN DOG EPITHELIM Bio-Rad Laboratories, Inc. | DHB |
| Oct 2, 1995 | K950728 | QUICKVUE ONE-STEP ALLERGEN SCREEN Quidel Corp. | DHB |
| Aug 15, 1995 | K953014 | ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN Diagnostic Products Corp. | DHB |
| Jun 30, 1995 | K945884 | SPECIFIC IGE ULTRA-EIA Hycor Biomedical, Inc. | DHB |
| Jun 7, 1995 | K945748 | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. | DHB |
| May 23, 1995 | K950629 | ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR Bio-Rad Laboratories, Inc. | DHB |
| Mar 21, 1995 | K931746 | LATEX (K82) Diagnostic Products Corp. | DHB |
| Mar 13, 1995 | K941278 | HY-TEC AUTOMATED EIA SYSTEM Hycor Biomedical, Inc. | DHB |
| Mar 6, 1995 | K943768 | HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT Diagnostic Products Corp. | DHB |
| Jan 20, 1995 | K941057 | SPECIFIC IGE EIA-ULTRA ASSAY Hycor Biomedical, Inc. | DHB |
| Dec 19, 1994 | K941564 | IMMULITE ALATOP ALLERGY SCREEN Diagnostic Products Corp. | DHB |
| Mar 22, 1994 | K935488 | ALATOP(R) MICROPLATE ALLERGY SCREEN Diagnostic Products Corp. | DHB |
| Mar 11, 1994 | K935876 | ACCESS SPECIFIC IGE ASSAY Bio-Rad Laboratories, Inc. | DHB |
| Mar 7, 1994 | K934524 | MAST CLA ALLERGY SYSTEM Mast Immunosystems | DHB |
| Mar 7, 1994 | K926420 | MAST CLA ALLERGY SYSTEM Mast Immunosystems | DHB |
| May 14, 1993 | K925044 | VENTREX ALLERGEN DISC Ventrex, Inc. | DHB |
| Feb 23, 1993 | K923420 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY Ciba Corning Diagnostics Corp. | DHB |
| Jan 14, 1993 | K925425 | SPECIFIC IGE EIA-TURBO ASSAY Hycor Biomedical, Inc. | DHB |
| Dec 1, 1992 | K924044 | VENTREX ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
| Nov 30, 1992 | K924209 | VENTREX ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
| Nov 30, 1992 | K924119 | VENTREX ALLERGEN DISC Ventrex, Inc. | DHB |
| Sep 28, 1992 | K923284 | BASELINE CALIBRATION VERIFICATION CONTROLS Hycor Biomedical, Inc. | DHB |
| Sep 14, 1992 | K914685 | 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS In Vitro Technologies, Inc. | DHB |
| Aug 20, 1992 | K914959 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. | DHB |
| Aug 3, 1992 | K921574 | WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
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