510(k) Report

Devices descending from K962274

37 later devices reach Unicap 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…Phadia AB20190—
+1K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutPhadia AB20180—
+1K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB20170—
+1K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440…Phadia AB20150—
+1K122197Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…Phadia US, Inc.201301
+1K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4…Phadia AB201301
+1K121156Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…Phadia AB201301
+1K113841Immunocap Allergen Components BundlePhadia US, Inc.20121—
+1K111919Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsPhadia US, Inc.20110—
+1K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap…Phadia AB20111—
+1K100999Immunocap Allergen F20, Almond Model: 14-4179-01Phadia AB20100—
+1K081830Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check…Phadia AB20091—
+1K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc.200601
+1K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB2005303
+1K993388Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59…Pharmacia & Upjohn Co.199902
+1K991048Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…Pharmacia & Upjohn Co.19992—
+1K974580Allergen Immunocap F256,F245,F207,F202Pharmacia & Upjohn Co.19981—
+2K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…Hycor Biomedical20260—
+2K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…Hycor Biomedical20260—
+2K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…Hycor Biomedical20260—
+2K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…Hycor Biomedical20260—
+2K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…Hycor Biomedical20260—
+2K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…Hycor Biomedical20250—
+2K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…Hycor Biomedical20250—
+2K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…Phadia AB20220—
+2K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical20220—
+2K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS…Hycor Biomedical20200—
+2K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovinePhadia AB20200—
+2K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002…Hycor Biomedical20190—
+2K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001…Hycor Biomedical20180—
+2K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB201611
+2K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mitePhadia AB20160—
+2K151029Phadia PrimePhadia AB201601
+2K092978Immunocap Rapid Reader, Model 12-3600-10Phadia US, Inc.20100—
+2K092050Immunocap Allergen D201, House Dust Mite, Model 4-4896-01Phadia AB20090—
+2K071913Immunocap Allergen F338, Scallop with Model (S): 14-4895-01Phadia AB20070—
+3K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.20240—