FDA 510(k) Applications for Medical Device Product Code "DHB"
(System, Test, Radioallergosorbent (Rast) Immunological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983954 | DIAGNOSTIC PRODUCTS CORP. | ALASTAT MICROPLATE MIXED ALLERGEN PANELS | 12/17/1998 |
| K023152 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | 12/17/2002 |
| K013134 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) | 10/15/2001 |
| K021208 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 MIXED ALLERGEN PANELS | 05/30/2002 |
| K021206 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 SPECIFIC ALLERGENS | 05/30/2002 |
| K973186 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE | 09/29/1997 |
| K963245 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE LATEX-SPECIFIC IGE | 11/18/1996 |
| K013135 | DIAGNOSTIC PRODUCTS CORP. | IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) | 10/19/2001 |
| K961889 | DIAGNOSTIC PRODUCTS CORP. | SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS | 10/10/1996 |
| K193613 | Hitachi Chemical Diagnostics, Inc. | Allergen-Specific IgE Assay 12 Allergen Bundle | 10/18/2021 |
| K112910 | HITACHI CHEMICAL DIAGNOSTICS, INC. | AP 72OS SEMI-AUTOMATED INSTRUMENT | 12/20/2012 |
| K182793 | Hitachi Chemical Diagnostics, Inc. | AP3600 Automated Instrument | 03/19/2019 |
| K030590 | HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) | 03/21/2003 |
| K051677 | HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | 01/23/2006 |
| K220162 | Hycor Biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | 02/18/2022 |
| K191510 | Hycor Biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | 07/31/2019 |
| K182479 | Hycor Biomedical | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | 12/04/2018 |
| K200825 | Hycor Biomedical | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | 06/26/2020 |
| K081217 | HYCOR BIOMEDICAL, INC. | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | 05/22/2008 |
| K080322 | HYCOR BIOMEDICAL, INC. | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | 03/05/2008 |
| K965094 | HYCOR BIOMEDICAL, INC. | HYCOR ALLERGEN DISC | 05/21/1997 |
| K020387 | IMMUNETECH CORPORATION | MYALLERGYTEST SYSTEM | 04/17/2002 |
| K121156 | PHADIA AB | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | 03/13/2013 |
| K092050 | PHADIA AB | IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 | 11/20/2009 |
| K101251 | PHADIA AB | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN | 05/27/2011 |
| K150597 | PHADIA AB | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | 02/29/2016 |
| K190315 | Phadia AB | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | 05/14/2019 |
| K100999 | PHADIA AB | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 | 12/15/2010 |
| K071913 | PHADIA AB | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 | 08/24/2007 |
| K212181 | Phadia AB | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | 08/03/2022 |
| K123275 | PHADIA AB | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM | 06/28/2013 |
| K200279 | Phadia AB | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | 05/01/2020 |
| K163370 | PHADIA AB | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | 05/05/2017 |
| K081830 | PHADIA AB | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 | 03/16/2009 |
| K131738 | PHADIA AB | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H | 07/10/2013 |
| K173726 | Phadia AB | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | 04/16/2018 |
| K150854 | PHADIA AB | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut | 12/14/2015 |
| K151029 | PHADIA AB | Phadia Prime | 01/19/2016 |
| K122197 | PHADIA US INC. | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | 08/28/2013 |
| K113841 | PHADIA US INC. | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | 09/13/2012 |
| K092978 | PHADIA US INC. | IMMUNOCAP RAPID READER, MODEL 12-3600-10 | 01/19/2010 |
| K111919 | PHADIA US INC. | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | 12/22/2011 |
| K993388 | PHARMACIA & UPJOHN CO. | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | 12/01/1999 |
| K974580 | PHARMACIA & UPJOHN CO. | ALLERGEN IMMUNOCAP F256,F245,F207,F202 | 02/09/1998 |
| K982343 | PHARMACIA & UPJOHN CO. | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 | 09/15/1998 |
| K000132 | PHARMACIA & UPJOHN CO. | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | 02/18/2000 |
| K991048 | PHARMACIA & UPJOHN CO. | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 | 05/14/1999 |
| K962976 | PHARMACIA & UPJOHN CO. | PHARMACIA CAP SYSTEM RAST FEIA | 12/23/1996 |
| K051218 | PHARMACIA DIAGNOSTICS AB | MODIFICATION TO: UNICAP SPECIFIC IGE | 06/09/2005 |
| K974350 | PHARMACIA, INC. | ALLERGAN IMMUNO CAP M4, M8, K70 | 02/09/1998 |
| K941993 | PHARMACIA, INC. | PHARMACIA CAP SYSTEM PHADIATOP FEIA | 01/30/1996 |
| K962274 | PHARMACIA, INC. | UNICAP 100 | 09/12/1996 |
| K972364 | PHARMACIA, INC. | UNICAP PHADIATOP | 09/04/1997 |
| K972068 | PHARMACIA, INC. | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | 07/03/1997 |
| K083314 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 03/11/2009 |
| K083853 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 03/24/2009 |
| K090257 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 05/26/2009 |
| K091289 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 08/06/2009 |
| K093107 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 09/30/2010 |
| K101572 | SIEMENS HEALTHCARE DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 08/01/2011 |
| K093987 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 | 03/28/2011 |
| K112523 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | 01/06/2012 |
| K132801 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY | 05/28/2014 |
| K091984 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | 10/28/2009 |
| K100910 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | 05/11/2011 |
| K121463 | Thermo Fisher Scientific | IMMUNOCAP ALLERGEN K82 | 01/29/2013 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
