510(k) Report

Devices descending from K051218

30 later devices reach Modification to: Unicap Specific Ige through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…Hycor Biomedical20260—
+1K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…Hycor Biomedical20260—
+1K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…Hycor Biomedical20260—
+1K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…Hycor Biomedical20260—
+1K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…Hycor Biomedical20260—
+1K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…Hycor Biomedical20250—
+1K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…Hycor Biomedical20250—
+1K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…Phadia AB20220—
+1K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical20220—
+1K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS…Hycor Biomedical20200—
+1K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovinePhadia AB20200—
+1K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002…Hycor Biomedical20190—
+1K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…Phadia AB20190—
+1K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001…Hycor Biomedical20180—
+1K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutPhadia AB20180—
+1K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB20170—
+1K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB201611
+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—
+1K092050Immunocap Allergen D201, House Dust Mite, Model 4-4896-01Phadia AB20090—
+1K071913Immunocap Allergen F338, Scallop with Model (S): 14-4895-01Phadia AB20070—
+2K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.20240—
+2K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mitePhadia AB20160—
+2K151029Phadia PrimePhadia AB201601