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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- HYQIron Chloride-Weigert1Product Code
- HYRLeuco-Patent Blue1Product Code
- HYSLight Green1Product Code
- HYTLuxol Fast Blue1Product Code
- HYWStain, Trichrome, Mallory'S1Product Code
- HYYMetanil Yellow1Product Code
- HYZMethenamine Silver1Product Code
- HZAMethyl Green1Product Code
- HZCMucicarmine1Product Code
- HZDMuller'S Colloidal Iron1Product Code
- HZENile Blue1Product Code
- HZFNuclear Fast Red1Product Code
- HZGOil Red O1Product Code
- HZHOrange G1Product Code
- HYHGold Chloride1Product Code
- HYIIodine, Grams1Product Code
- HYJHematoxylin1Product Code
- HYKHematoxylin Harris'S1Product Code
- HYLHematoxylin Mayer'S1Product Code
- HYOHematoxylin Weigert'S1Product Code
- GGHIron Stains1Product Code
- GHZSolution, Gugol Blue1Product Code
- HYBEosin Y1Product Code
- HYCFast Green1Product Code
- HYDFast Red Salt B1Product Code
- HYESolution, Fontanna Silver1Product Code
- HYFGiemsa Stain1Product Code
- HYGGlenner'S Stain1Product Code
- HZJStain, Papanicolau1Product Code
- HZLPhloxine B1Product Code
- HZMHematoxylin, Acid, Phosphotungstic1Product Code
- HZNPicro Methyl Blue1Product Code
- HZOStain, Ponceau1Product Code
- HZPPyronin1Product Code
- HZQRed-Violet Lb1Product Code
- HZRResorcin Fuchsin1Product Code
- HZSSafranin1Product Code
- HZTReagent, Schiff1Product Code
- HZXSilver Nitrate1Product Code
- HZYSirius Red1Product Code
- HZZSudan Black B1Product Code
- IAATitan Yellow1Product Code
- IABToluidine Blue1Product Code
- IACVan Gieson'S Stain1Product Code
- IADVan Gieson'S Picro-Fuchsin1Product Code
- IAEHematoxylin, Iron, Weigert'S1Product Code
- IAFWright'S Stain1Product Code
- ICCEosin B1Product Code
- ICDDarrow Red1Product Code
- ICFCrystal Violet For Histology1Product Code
- ICGCresyl Violet Acetate1Product Code
- ICHCongo Red1Product Code
- ICIHematoxylin, Chrome Alum1Product Code
- ICJCarbol Night Blue1Product Code
- ICLCarbol Fuchsin1Product Code
- ICMBrilliant Yellow1Product Code
- ICNBiebrich Scarlet1Product Code
- ICOBest'S Carmine1Product Code
- ICQAzure A1Product Code
- ICRAzocarmine B1Product Code
- ICSAzocarmine G1Product Code
- ICTAzan Counterstain1Product Code
- ICXAniline1Product Code
- ICYAcid, Aniline, Fuchsin1Product Code
- ICZAmmoniacal Silver Hydroxide Silver Nitrate1Product Code
- IDAAlcian Blue1Product Code
- IDBAldehyde Fuchsin1Product Code
- IDCAcridine Orange1Product Code
- IDDAlizarin Red1Product Code
- IDEAcid, Hematein1Product Code
- IDFAcid, Fuchsin1Product Code
- JCHEsterase1Product Code
- JCIAcid Phosphatase, Cytochemical1Product Code
- KFCMethylene Blue, Tissue Stain1Product Code
- KFDAniline Blue1Product Code
- KFENeutral Red1Product Code
- KJKAuramine O1Product Code
- KJLAzure C1Product Code
- KJMBismarck Brown Y1Product Code
- KJNBrilliant Cresyl Blue1Product Code
- KJOBrilliant Green1Product Code
- KJPCarmine1Product Code
- KJQChlorazol Black E1Product Code
- KJRErythrosin B1Product Code
- KJSEthyl Eosin1Product Code
- KJTIndigocarmine1Product Code
- KJWJanus Green B1Product Code
- KJXJenner Stain1Product Code
- KJYMalachite Green1Product Code
- KJZMartius Yellow1Product Code
- KKAMethyl Orange1Product Code
- KKBMethyl Violet 2b1Product Code
- KKCMethylene Violet1Product Code
- KKDNigrosin1Product Code
- KKEOrange Ii1Product Code
- KKFOrcein1Product Code
- KKGProtargol S1Product Code
- KKHTablet, Resazurin1Product Code
- KKIRose Bengal1Product Code
- KKJSudan Iii1Product Code
- KKKSudan Iv1Product Code
- KKLThionin1Product Code
- KKMMethylene Blue Thiocyanate1Product Code
- KKPSolution, Silver Carbonate1Product Code
- KKQSodium Periodate1Product Code
- KKRPotassium Periodate1Product Code
- KKSAcid, Periodic1Product Code
- KKTHematoxylin, Ehrlich'S1Product Code
- KKWBasic Fuchsin1Product Code
- KQCStains, Hematology1Product Code
- LEDStains, Chemical Solution1Product Code
- LEEStains, Dye Solution1Product Code
- LEFStains, Dye Powder1Product Code
- LGYTrypan Blue1Product Code
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor2Product Code
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor2Product Code
- NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer2Product Code
- NJTImmunohistochemistry Reagents And Kits1Product Code
- NJWControl Material, Her-2/Neu, Immunohistochemistry2Product Code
- NKFImmunohistochemistry Antibody Assay, C-Kit3Product Code
- NOTMicroscope, Automated, Image Analysis, Operator Intervention2Product Code
- NQFImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor3Product Code
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity2Product Code
- NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells1Product Code
- OEOAutomated Digital Image Manual Interpretation Microscope2Product Code
- K142965Virtuoso System for IHC PR (1E2) using iScan HT2Cleared 510(K)
- K131140OMNYX IDP FOR HER2 MANUAL APPLICATION2Cleared 510(K)
- K130021PHILIPS HERCEPTEST DIGITAL SCORE2Cleared 510(K)
- K111914VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM2Cleared 510(K)
- K080254SCANSCOPE XT SYSTEM2Cleared 510(K)
- K071671SCANSCOPE XT SYSTEM2Cleared 510(K)
- PDOEarly Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization2Product Code
- PFGDna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders2Product Code
- QNHImmunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay3Product Code
- PZJLynch Syndrome Test System2Product Code
- PRBCervical Intraepithelial Neoplasia (Cin) Test System2Product Code
- QULImmunohistochemistry Assay, Antibody, Folr13Product Code
- QZJImmunohistochemistry Assay, Antibody, Claudin 183Product Code
- SBLImmunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A43Product Code
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
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- UnknownReview Panel
OMNYX IDP FOR HER2 MANUAL APPLICATION
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K131140
- 510(k) Type
- Traditional
- Applicant
- OMNYX, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/1/2014
- Days to Decision
- 344 days
- Submission Type
- Summary